This is a selection of responses the U.S. Food and Drug Administration 
provided the International Consortium of Investigative Journalists and its 
partners in November 2018.  
 
ICIJ Q3: The 21st Century Cures Act includes provisions that require FDA regulators to use the “least 
burdensome” approach to demonstrating safety and effectiveness to approve new products and to train its 
staff in this concept. What was the industry’s role in influencing this language? Should the public be 
concerned by a law that ties the FDA’s hands by legally binding regulators to the “least burdensome” 
approach to regulation? 
FDA RESPONSE TO Q3: The “least burdensome” approach has long been misunderstood. It is a balanced method 
that is intended to allow the FDA to focus its resources on issues of highest public health concern. Timely patient 
access to high-quality, safe and effective medical devices requires that the FDA reduce or remove outdated, 
unnecessary burdens in our regulatory approaches that can otherwise add to development costs or forestall beneficial 
innovation without also enhancing device safety and effectiveness. Gathering and reviewing unneeded information 
is not beneficial to giving patients that timely access and hinders the FDA’s ability to optimally protect patients by 
misapplying our limited resources. In the case of mobile medical apps for general wellness, for instance, many 
consumers count on low risk apps to help plan their diet and exercise. Patients don’t benefit from FDA premarket 
review of such apps, which Congress recognized when, in the 21st Century Cures Act, they removed such apps from 
FDA oversight. Patients are better served when the FDA’s resources are spent on higher-risk, and novel products. 
In our 2017 draft guidance, the FDA defined least burdensome to be “the minimum amount of information 
necessary to adequately address a regulatory question or issue through the most efficient manner at the right time 
(e.g., need to know versus nice to know). Our least burdensome principles do not change the applicable regulatory 
standards, such as the device approval or clearance standards, nor the applicable requirements, including premarket 
submission content requirements and the requirement for valid scientific evidence. In fact, the least burdensome 
approach enables the FDA to establish a modern framework for making sure the agency continues to strengthen and 
secure its high standard for medical product review. 
In the past few years, we’ve seen notable results of our application of the least burdensome principles on medical 
device review, including improved quality of applications. 
 

 The genesis of the “least burdensome” approach dates back to 1997, when Congress directed the FDA to take a least 
burdensome approach to premarket evaluation. Congress enacted additional least burdensome provisions in 2012 
and in the 2016 21st Century Cures Act. During the legislative process for the 21st Century Cures Act, we worked 
with congressional members, their staff and industry to ensure that the enacted provisions would best serve the 
interests of patients. Congress also proactively solicited feedback from the stakeholder community on the provisions 
in the 21st Century Cures Act and, there was an opportunity for anyone impacted by the proposed legislation to 
provide their perspectives.1 
Given the benefits of this approach, the FDA made it agency policy in a 2002 guidance to apply the least 
burdensome approach to the postmarket evaluation of devices, as well. In the 2017 draft guidance, we have 
proposed to apply it across the total product lifecycle – beyond what Congress has required – including all 
device-related regulatory decisions. 
As we work to encourage innovation and advancement in the market, patient safety is and will remain a cornerstone 
of our regulatory commitment. The application of the least burdensome approach is important for meeting this 
commitment. 
 
ICIJ Q6: Do adverse event reports filed with the FDA reflect an accurate view of problems with medical 
devices? If so, why, and if not, why not? 
FDA RESPONSE TO Q6: Medical Device Reports or MDRs submitted to the FDA are only one source we use to 
monitor marketed medical devices. These reports may contribute to the detection of potential device-related safety 
issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of 
information, this type of reporting system has limitations, including the potential submission of incomplete, 
inaccurate, untimely, unverified, or biased data. Confirming whether a device actually caused a specific event can be 
difficult based solely on information provided in a given report. Complaints or adverse event reports do not 
necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to 
establish or compare rates of event occurrence. Additionally, we may receive multiple reports related to the same 
event making it difficult to determine actual numbers of events. 
FDA has long stated that the current system of post-market surveillance has limitations in promptly and consistently 
identifying safety risks, a challenge that is not unique to the U.S. The FDA discussed these limitations and proposed 
the steps necessary to address them, including the creation of a national system, in a 2012 document titled, 
Strengthening our National System for Medical Device Postmarket Surveillance and, over the past six years, the 
FDA, in collaboration with other stakeholders, has led the effort to establish the National Evaluation System for 
health Technology (NEST). In our 2012 document, we proposed that the national system – NEST – have active 
surveillance capabilities to complement our adverse event reporting (passive surveillance) system. Active 
surveillance involves actively and continuously generating, accessing, and evaluating large data sets on device 
performance and clinical outcomes associated with device use in routine clinical practice. Active surveillance has 
the potential to empower stakeholders to make timelier, evidence-based decisions. Here’s a link to more details on 
our NEST goals: 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReport 
s/ucm301912.htm  
In addition, the FDA established the unique device identification (UDI) system, which allows for more accurate 
reporting and analyzing of adverse events so that new and increased known safety issues can be identified and 
corrected more quickly. The UDI system will also help in the effort to drive change toward an active surveillance 
system and contribute to our work helping to create new real-world data sources. The continuing implementation of 
1

​https://psmag.com/news/in-praise-of-public-comments 

 the UDI system will improve the quality of information in medical device adverse event reports, help the FDA 
identify device problems more quickly, and better target recalls to improve patient safety. And, the agency continues 
working with the International Medical Device Regulators Forum on adoption of the UDI globally. This is another 
example of how the FDA has been at the forefront of developing innovative frameworks for collecting real world 
data, particularly in the field of device safety. Establishment of the UDI system has been a tremendous milestone in 
building a stronger, more modernized medical device safety net. The UDI provides a standard and clear way to 
document device use, including in electronic health records, clinical information systems, claims data sources, and 
registries. 
In addition, UDI provides a mechanism to reduce medical errors by enabling health care professionals and others to 
more rapidly and precisely identify a device and obtain important information concerning the device’s 
characteristics, which also prevents confusion between similar devices that can lead to device misuse. UDI provides 
a mechanism to help device manufacturers, distributors, and health care facilities manage device recalls more 
effectively. UDI also provides a foundation for a global, secure distribution chain, helping to address counterfeiting 
and diversion and prepare for medical emergencies. 
In our April 2018 Medical Device Safety Action Plan, we proposed next steps for creating these active surveillance 
capabilities, which we believe is now possible in light of the steps we have already taken. 
 
ICIJ Q9: How does the FDA ensure recall notices reach doctors, hospitals, distributors and patients? At what 
point is a recall, or a series of recalls, serious enough that a product must be removed from the market 
altogether? 
FDA RESPONSE TO Q9: The FDA takes problems with medical devices very seriously, and recalls are one method 
the agency uses to alert the public of potential safety issues, ensure manufacturers make key improvements to 
devices that are on the market and, when necessary, facilitate removal of a device from the market to protect the 
public health. Typically, a product must be removed from the market when a correction – i.e. a repair, modification, 
adjustment, relabeling, destruction or inspection (including patient monitoring) -- cannot fix the problem and/or 
reduce the risk to health (see 21 CFR 7.3(h)).Recalls occur when a medical device violates the Food, Drug & 
Cosmetic Act (e.g. adulterated or misbranded), when it could be a risk to health, or when it is both violative of the 
Act and a risk to health. Addressing a recall can involve a broad range of actions depending on the severity of the 
problem they are meant to correct – from changing the device’s labeling, providing training, or implementing a 
software patch, to removing the device from the market altogether. Therefore, a medical device recall can take many 
forms, and does not always mean that one must stop using the product or return it to the company. A recall 
sometimes means that the medical device needs to be checked, adjusted or fixed. 
In each case, the FDA thoroughly reviews the recall strategy the company proposes to address the problem, carefully 
assesses the health hazard presented by the product, works to quickly determine if the problem violates FDA law, 
potential violations of FDA requirements, and if appropriate, assigns the recall a classification (I, II, or III) to 
indicate the relative degree of risk (Class I recalls being the highest risk). 
A recalling firm is responsible for promptly notifying each of its affected direct accounts (e.g. a distributor) about 
the recall. Depending on the severity of the problem and extent of the device’s distribution, the recall strategy will 
specify how far in the distribution chain notification must be provided (e.g. consumer or user level, retail level or 
wholesale level). The FDA also conducts effectiveness checks for higher risk recalls (e.g., Class I) to verify that all 
identified persons or entities specified by the strategy have received notification about the recall and have taken 
appropriate action. In addition, depending on the product and reason for recall, the FDA often works with 
professional medical societies and hospital organizations directly to distribute and amplify the recall message. 
Once classified, the FDA closely monitors the recall to ensure that the recall strategy has been effective. Only after 

 the FDA is assured that a product no longer violates the law and no longer presents a health hazard, does the FDA 
terminate the recall. 
When a company initiates a correction or removal action, the FDA posts information online about the action in the 
Medical Device Recall Database and updates the database after it classifies the recall and again after it terminates 
the recall. In addition, the FDA may post company press releases or other public notices about recalls, market 
withdrawals and safety alerts that may potentially present significant risks to patients and other users of the product. 
After a recall has been classified, the FDA notifies the public in the agency’s weekly Enforcement Report. In 
addition, the FDA posts consumer information about Class I and some Class II and III recalls in order to ensure that 
patients are aware of the seriousness of the potential health hazard posed by exposure to the product. Other efforts 
include public notifications via the FDA’s MedWatch alert system, general and targeted emails to the health care 
and patient community and distribution via various FDA social media channels targeted at health care providers, 
patients and consumers. These actions are complementary to the notifications provided by the recalling firm. 

 
ICIJ Q11: Annual FDA warning letters to device companies have fallen nearly 90 percent since 2010, 
reaching a record low of just 25 letters issued in the last fiscal year. Are companies more compliant with FDA 
rules and regulations than in the past or is there some other reason for the decline? 
FDA RESPONSE TO Q11: Our most fundamental obligation to the American public is providing patients with 
access to safe and effective medical products to meet their health care needs while also protecting them from 
harmful products and deceptive medical claims. When a manufacturer, its facility or its product is not compliant 
with FDA requirements, the agency has several options to assure appropriate actions are taken to correct the 
problem and prevent future recurrence, including issuing a warning letter, issuing an Untitled Letter and conducting 
a regulatory meeting. The FDA determines which action to take based on a variety of factors. 
Rather than decrease its oversight, the FDA has increased the annual number of device inspections it conducts by 57 
percent since 2007. Through implementation of a risk-based inspection approach that focuses on “high-risk” firms 
and/or products, the annual number of Official Action Indicated (OAI) inspections has increased 59 percent. In total, 
efforts to increase the number of inspections and to focus on firms/products most likely to be violative, has increased 
the number of firms identified as needing corrective actions. 
The agency took a more aggressive approach to the issuance of warning letters beginning in 2008 and reaching a 
peak in 2012, when 189 warning letters were issued, representing a more than seven-fold increase in the annual 
number of warning letters in 2012 compared to 2007. The agency has routinely conducted follow-up inspections of 
violative firms, and in general, more than 75 percent of firms have corrected their violations on follow-up 
inspection. The annual increase in warning letters during this time period did not impact the rate of firms that 
corrected their violations on follow-up inspection. 
More recently, the agency has been more interactive with violative firms. In particular, agency staff review firm 
responses to the Form 483 (which notifies the company of objectionable conditions), provide feedback on firm’s 
proposed corrective action plans, and monitor progress toward remediation. Issuance of warning letters has focused 
on firms who have more severe violations or who fail to implement or follow-through on their corrective action plan 
in a timely fashion. This more interactive approach has resulted in a decrease in the annual number of warning 
letters while maintaining a 75 percent rate of firms that demonstrate correction of their violations on follow-up 
inspection. 
In short, one cannot get a full picture of the FDA’s oversight and industry compliance by looking at warning letters 
alone. 
Further, in 2011, the FDA launched the Case for Quality, an initiative undertaken in collaboration with 

 other members of the device ecosystem, to identify those practices that can promote a culture of quality and the 
implementation of a quality management approach that fosters continuous product improvement. 
 
ICIJ Q18: In the history of the FDA, only two devices have been banned. Why so few, given acknowledged 
major safety issues with many more than that? What does it take for FDA to ban a medical device? 
FDA RESPONSE TO Q18: The FDA has used this authority twice and has proposed to use it once more (the latter 
of which was announced in a proposed rule that is still pending). (More information on bans is available here: 
https://www.fda.gov/medicaldevices/safety/medicaldevicebans/default.htm​.) We are bound by federal law to follow 
certain criteria that must be met in order to ban a device: the FDA must determine, on the basis of all available data 
and information, that a device presents substantial deception or an unreasonable and substantial risk of illness or 
injury that cannot be corrected or eliminated by changes in labeling or advertising. The FDA may consult with the 
appropriate classification panel before initiating a proceeding to ban a device. To implement a ban, the FDA must 
issue a proposed rule, consider public comments, and issue a final rule. For additional information, see section 516 
of the Federal Food, Drug & Cosmetic Act, 21 CFR 895.20, and 21 CFR 895.21. 
In cases where safety issues are present that warrant a device being removed from the market, the FDA typically 
works directly with companies. Voluntary recalls are used in the vast majority of these cases and generally result in 
a faster action to remove than the mandatory recall process or going through rulemaking to ban the device. More 
commonly, identified safety issues can be effectively addressed through other measures rather removal from the 
market, including changes in labeling or in the design of the device. The FDA’s experience is overwhelmingly that 
companies will voluntarily correct the problems—either on their own or at the FDA’s request— so that the device 
can remain on the market. 

 
ICIJ Q20: What share of medical devices approved by the FDA in 2017 were cleared via the 510k pathway? 
How many class III product types were cleared through 510k? 
FDA RESPONSE TO Q20: 82 percent of medical devices approved/cleared by CDRH in calendar year 2017 were 
cleared via the 510(k) pathway. 
During calendar year 2017, no class III product types (classification regulations or product codes) were cleared 
through the 510(k) process. 

 
ICIJ Q28: The FDA has said “the benefits and risks of breast implants are sufficiently well understood for 
women to make informed decisions about their use.” How did the agency reach that conclusion? The FDA’s 
own data show that failure rates are high. Why is the agency confident that women understand the risks? 
FDA RESPONSE TO Q28: As a public health agency, we play an important role in ensuring that patients seeking 
breast augmentation and breast reconstruction have accurate information regarding the benefits and risks to make 
informed decisions on whether implants may be right for them. Breast implants are not lifetime devices and over the 
past 30 years we have public communicated the potential risks with patients and providers that may come from their 
use. We continue to maintain a detailed website on breast implants, which contains information about breast 
implant-associated anaplastic large cell lymphoma (BIA-ALCL), risks of breast implants, product labeling and 
more. We’ve also issued communications when we obtain new information about BIA-ALCL to ensure that patients 
and providers are updated with information about BIA-ALCL when making choices about breast implants. 
In fact, one of the conditions of approval for breast implants put back onto the market in 2006 were focus group 
studies. All three sponsors have completed these studies to evaluate how easily patients understand the information 

 in the informed decision brochure about the risks associated with the use of silicone breast implants. Overall 
reaction to two versions of brochures tested was positive (Mentor’s PAS#6 posted to PAS website). Allergan and 
Mentor have also completed studies on the “Informed Decision Process,” which is an annual survey sent to 50 
randomly selected physicians that asks questions on the level of understanding a patient has after consultation with a 
patient planner. In the Allergan study, the majority (85.7%) of respondents were satisfied with the Patient Planner, 
with 55.9% rating it Very Good and 29.8% rating it Good (Allergan’s PAS#6 posted to PAS website). In the Mentor 
study, the majority of respondents (94.2%) reported that the Informed Decision Brochure was of value in helping 
patients understand the risks and benefits of implant surgery. (Mentor’s PAS#3 posted to PAS website). 
The FDA regularly updates our post-approval studies webpage on breast implants and has also recently updated the 
webpage to make the information easier to understand. The FDA has and will continue to communicate any 
additional updates we have to share about breast implants and any potential links to diseases or conditions. 
The FDA also encourages patients and providers to discuss the benefits and risks of breast implants. Choosing to 
obtain a breast implant is a very personal decision that patients and their providers should make based on individual 
needs and with the most complete information. 
The FDA continually reassesses whether it should take additional actions to protect patients. As noted, in our 
response to Question 5, we announced in September our plan to hold a public meeting of our Medical Devices 
Advisory Committee in 2019 related to breast implant safety and effectiveness. The purpose of this meeting is to 
discuss the evolving science and give patients, health care providers, and other members of the public an opportunity 
to be heard. This will help the FDA determine if additional actions may be necessary to protect the public health, 
including to require a black box warning, a patient safety checklist, or other actions to assure patients understand the 
benefits and risks of breast implants to make informed decisions. 
For more information, please see our statement released in September regarding breast implants. 
 
ICIJ Q30: In a meeting on Sept. 5, patient advocates met with the FDA and called for steps to protect patient 
safety including a black box label warning, a ban on textured implants and a patient safety checklist. Is the 
FDA considering these or any other measures to further inform and protect the public from possible safety 
risks associated with breast implants? 
FDA RESPONSE TO Q30: Yes, we are considering additional measures with regard to breast implants. The agency 
relies on patients for important feedback to help us learn more about the benefits and risks of medical products when 
they’re used outside of clinical trials in the real world. We appreciate their direct feedback and are looking for more 
ways to incorporate the patient experience so that we focus on the things that matter to them. 
In the FDA’s meeting with patient advocates on September 5, the group provided their perspectives as patients and 
researchers regarding breast implants and identified several opportunities for improved understanding and 
communication regarding breast implant risks and benefits. The information they shared is valuable and important 
for us to be aware of to be effective regulators serving the needs of patients. And, in light of the growing science 
regarding the benefits and risks of breast implants since our last advisory committee meeting in 2011, we announced 
in September that we plan to hold a public meeting of our Medical Devices Advisory Committee in 2019 to discuss 
the evolving science and to give patients, health care providers, and other members of the public an opportunity to 
be heard and promote an open public dialogue. This will help inform FDA as to whether we should take additional 
actions to protect patient safety including a black box label warning, a ban on textured implants, a patient safety 
checklist, or other steps. 

 

  
ICIJ Q7. How does the FDA coordinate with similar government regulators around the world, both in the 
developed world like the EU as well as in developing and BRICS nations such as India and South Africa? 
FDA RESPONSE TO Q7: 
FDA is a founding member of the International Medical Device Regulators Forum (IMDRF), which is the primary 
mechanism through which the agency focuses on international activities with respect to medical devices. IMDRF 
consists of medical device regulators from around the world that have voluntarily come together to harmonize the 
regulatory requirements for medical devices. The FDA participates in IMDRF alongside Australia, Brazil, Canada, 
China, Europe, Japan, Russia, South Korea, and Singapore. The World Health Organization (WHO) is an Official 
Observer and APEC's Life Sciences Innovation Forum's Regulatory Harmonization Steering Committee, the Asian 
Harmonization Working Party (AHWP) and the Pan American Health Organization (PAHO) are Regional 
Harmonization Initiatives with IMDRF. 
While the members of IMDRF are developed countries with robust regulatory systems, developing countries 
participate through the Regional Harmonization Initiatives. The FDA works alongside other IMDRF members in 
working groups to develop internationally agreed upon guidance documents on specific topics such as adverse event 
reporting, standards and Unique Device Identification (UDI). Once created, these internationally agreed upon 
documents are then adapted by IMDRF members to meet the regulatory requirements of their jurisdictions. 
One of the main goals of IMDRF is for regulators to work together to confront key challenges, develop approaches 
for new and emerging technologies, and improve the safety and quality of medical devices around the world. Some 
of the areas where the FDA is helping to lead the world to enhance the safety of medical devices include work with 
IMDRF on universal adoption of UDI, and improving cybersecurity of medical devices globally. 
Additionally, the FDA has taken the lead to identify and act on safety signals internationally. For example, the 
agency has worked for years to improve the safety of infusion pumps, first issuing a letter to infusion pump 
manufacturers back in 2010 to alert them and the public about MDRs, and has since worked to increase user 
awareness of safety issues on an international level, facilitate improvements to these important devices, and publish 
guidance to assure the safety of these devices throughout their total product life cycle. Likewise, it was the FDA that 
led efforts to better understand and address the safety signals related to metal-on-metal hips. In 2010, the FDA 
launched the International Consortium of Orthopedic Registries (ICOR), an international collaborative effort 
designed to advance the harmonization, interoperability and quality of hip and joint replacement registries 
worldwide. A total of 29 registries participate in this collaboration that collectively captures experience of more than 
5.2 million patients from 14 nations worldwide. The ICOR developed minimum core data set for hips and knees, 
harmonized definitions globally, developed methodology to combine the data from multiple countries and conducted 
combined analyses including those focusing on metal-on-metal hips. The FDA leveraged ICOR capabilities and 
included ICOR registry presentations in an FDA panel meeting focusing on metal-on-metal hips to help inform the 
regulatory decision making. The FDA engages heavily with our international counterparts to share information 
about potential safety concerns with medical devices, and to identify and take action to protect patients and the 
public health where possible. 
While stakeholders may participate in some IMDRF working groups, the voting membership in the IMDRF 
management committee is exclusive to regulators, which was one of the preconditions the FDA specified when we 
first proposed the creation of IMDRF in 2010 and 2011 in contrast to the entity it replaced – the Global 
Harmonization Task Force – which included device industry representation. This structure allows regulators to share 
confidential information about their respective programs and capabilities in order to implement several of the 
IMDRF adopted actions, and ensure regulators themselves are making the decisions for the practices their respective 
nations will follow. Even in the case of standards development and recognition, where outside stakeholders can 

 propose standards for the FDA’s recognition – it is the FDA that has the final say and makes the decision. For 
additional information on IMDRF, including the documents developed by IMDRF, please refer to: ​www.imdrf.org​.  

 
ICIJ Q5: [ICIJ question regarding devices such as the birth control implant Essure and breast implants that 
have been associated with patient harm.] What kind of evidence would you require to order either product 
from the market -- or, in the case of breast implants, require a black box warning? 
FDA RESPONSE TO Q5: 
A key aspect of the FDA’s mission is to provide patients with timely and sustained access to high-quality, safe, and 
effective medical devices. In reviewing premarket submissions, the agency balances the benefits and risks to patients 
from the use of a device based on the totality of the scientific evidence. As with any medical product, some risks 
may become evident in the postmarket setting after approval, which is why the FDA imposes postmarket 
requirements and controls, investigates safety signals, and communicates safety concerns to manufacturers, health 
care providers, and patients. We also believe it’s important to partner with patient groups, medical professional 
societies, academic institutions, and industry to understand possible risks from medical devices. 
When the FDA learns of a safety concern, the agency determines the appropriate course of action based on the 
specific facts, risks and benefits of the device. The FDA might ask the manufacturer to voluntarily take risk 
mitigation steps, such as labeling changes or removal of a product from the market. We realize that there might be 
confusion about why we take this approach instead of invoking a formal regulatory process, such as banning a 
device. The reason is that this approach of voluntary manufacturer action with FDA oversight is often the most 
expeditious and efficient way to address a safety problem, which is in the best interests of patients. When the FDA 
takes formal action, the agency must demonstrate that the statutory criteria for action have been met, and then 
initiate the regulatory process. For example, to ban a device, the FDA must determine that the device presents 
“substantial deception or an unreasonable and substantial risk of illness or injury,” and then promulgate a regulation 
to make the device a banned device, a regulatory process that can take years to complete (FD&C Act section 516). 
It is important to note that our approach to regulation for all medical devices is evidence- and science- based, and the 
decisions we make are grounded in a thorough review of the totality of available evidence, not all of which may be 
reflected in the public discourse around a particular product. 
For example, the FDA has been extremely focused on the safety profile of the Essure permanent birth control device 
and has taken a series of escalating actions to address concerns based on available evidence of the risks. These 
actions, which have included adding a boxed warning and patient decision checklist to the device labeling, were 
intended to implement meaningful safeguards to ensure women are able to make an informed decision when 
considering this device. The FDA was notified by Bayer that they will no longer sell or distribute the Essure device 
after Dec. 31, 2018 for business reasons as they had been doing in other countries. 
The post-market safety of Essure continues to be a top priority for the FDA, and even when Essure is no longer sold, 
the FDA will remain vigilant in protecting patients who’ve already had this device implanted. Information about 
FDA’s actions related to Essure can be found here: 
https://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/essure 
permanentbirthcontrol/ucm452254.htm   
Our regulation of breast implants is based on decades of work we have done to assess and communicate the benefits 
and risks of these products. The steps we’ve taken date back to 1988, when, based on emerging safety concerns, the 
FDA reclassified breast implants from Class II (moderate risk) to Class III (high risk) devices requiring 
manufacturers to submit a pre-market approval application before the device could be marketed. 
In 1992, the FDA expressed concern about the available safety data for silicone implants and announced a voluntary 

 moratorium on all silicone implant sales in the U.S. pending further review of safety information. This moratorium 
was lifted in 2006 with the approval of new silicone implants that met the FDA’s standards for safety. As conditions 
of approval, each manufacturer was required to conduct six post-approval studies to further characterize the safety 
and effectiveness of their silicone gel-filled breast implants and to answer additional scientific questions about the 
long-term safety of breast implants that the premarket clinical trials were not designed to answer. As part of these 
post-approval studies, the FDA collected data from the studies totaling nearly 100,000 patients. We communicated 
the results of these post-approval studies in our 2011 report, which noted that breast implants are not lifetime 
devices and have a reasonable assurance of safety and effectiveness when used as labeled. 
While the agency continues to believe that the weight of the currently available scientific evidence does not 
conclusively demonstrate an association between breast implants and connective tissue diseases, we welcome and 
will thoroughly evaluate new studies on this important topic. These studies, such as the recent publication in Annals 
of Surgery, contribute to our discourse on this topic, but more evaluation is required as we noted in an 
accompanying editorial and statement about this study. 
To help generate additional data about these devices, the FDA has worked with stakeholders who have launched two 
breast implant registries, the National Breast Implant Registry (NBIR) and Patient Registry and Outcomes for Breast 
Implants and Anaplastic Large Cell Lymphoma Etiology and Epidemiology (PROFILE), to help strengthen 
available real-world data for breast implants in the U.S. Registry data. These registries are being used to evaluate the 
safety of breast implants in combination with the information from medical device reports, the medical literature, 
and post-approval studies. At this time, the FDA does not have sufficient evidence of an association between breast 
implants and illnesses other than BIA-ALCL. Our participation in PROFILE and NBIR demonstrate our 
commitment to collecting evidence on BIs. Of note, we were one of the first countries to recognize and inform the 
public about the association between breast implants and anaplastic large cell lymphoma and helped launch these 
registries to better understand this association and its cause(s). 
Patients and health care providers are valuable partners in this effort when they report any problems they observe 
with breast implants to the FDA through the MedWatch program. 
Additionally, in light of the growing science regarding the benefits and risks of breast implants since our last 
advisory committee meeting in 2011, we announced in September our plans to hold a public meeting of the General 
and Plastic Surgery Devices Panel of our Medical Devices Advisory Committee in 2019. The purpose of this 
meeting is to ensure that patients and health care providers continue to have accurate, scientifically sound 
information about breast implant safety and effectiveness, and to promote public dialogue on the issue. Advisory 
committees like this one serve to provide the FDA with independent advice from outside experts. This committee 
will likely include several members from the medical community, academia, industry, and importantly, patient 
representatives. This meeting will be to encourage discussion of the evolving science, such as any relationship 
between texturing and BIA-ALCL, and give patients, health care providers, and other members of the public an 
opportunity to be heard. This meeting will help the FDA determine if additional actions may be necessary to protect 
the public health in the case of this particular device, including to require a black box warning. The FDA will 
continue to provide the public with new information as it becomes available. 
 
 
ICIJ Q12: In 2012, CDRH set a new goal -- Dr. Shuren has called it “our north star” -- of being “first in the 
world” to introduce new medical devices. When exactly was this goal first publicly announced or posted? To 
what extent was it a response to industry criticism that the FDA was slower to approve new devices than 
regulators in Europe? Was the new goal approved prior to implementation by then-FDA Commissioner 
Hamburg or Health and Human Services Secretary Sebelius? If so, please provide documentation, including 
the date, of the decision. If not, why was such a significant goal made without input of FDA and HHS 

 leadership? 
FDA RESPONSE TO Q12: 
In 2012, the FDA announced a Vision for its medical device program to help achieve its public health mission to 
both protect and promote public health. This goal was made with the support of FDA and HHS leadership, including 
then-Secretary Sebelius. The FDA strives to protect public health by assuring that medical devices are safe and 
effective. It also strives to promote public health by facilitating medical device innovation and timely patient access 
to safe and effective technologies. CDRH’s Vision is more expansive than “first in the world,” and not considering 
this Vision in its entirety would be misleading to its intent, particularly as the agency has been taking concurrent 
actions to implement all of its parts. Our full Vision statement is the following: “Patients in the U.S. have access to 
high-quality, safe, and effective medical devices of public health importance first in the world. The U.S. is the 
world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product 
safety. U.S. post- market surveillance quickly identifies poorly performing devices, accurately characterizes 
real-world performance, and facilitates device approval or clearance. Devices are legally marketed in the U.S. and 
remain safe, effective, and of high-quality. Consumers, patients, their caregivers, and providers have access to 
understandable science-based information about medical devices and use this information to make health care 
decisions.” 
Then-Secretary Sebelius made her support for this Vision and CDRH’s overall mission clear on April 10, 2012 
through a videotaped message to CDRH staff about the public release of our Vision and the availability of the 
Innovation Pathway 2.0 pilot, the progenitor for the current Breakthrough Devices Program. And, CDRH has 
included its Vision in each release of the Center’s Strategic Priorities, which are discussed with the Commissioner 
and reviewed by the Commissioner’s Office prior to public release and posting on the FDA’s website. These 
Strategic Priorities include the actions the Center commits to take and the goals it commits to achieve to assure 
public accountability. Over the years, in an effort to promote transparency, CDRH has continued to report to the 
public on the progress it has made on completing these actions and achieving these objective metrics. The Center 
includes its Vision in many of the presentations it gives to members of the public throughout the year, as well as in 
congressional testimony and in material for and responses to the media. 
With regard to helping ensure that U.S. patients are first in the world to have access to high-quality, safe and 
effective medical devices, we have stated over the years that this is not about a competition between countries, but 
rather a reflection of our mission that we want devices to benefit patients, but only when a device is safe and 
effective. This objective reflects our concerns about the delay we observed between when pioneering new 
technologies were reaching U.S. patients as compared to other developed countries, putting U.S. patients at risk. 
Our Vision also acknowledges that safe and effective medical devices are of limited benefit to patients if they do not 
have timely access. Approving a safe and effective device five years later than we otherwise could does not benefit 
patients. “First in the world” is simply a good metric for timely patient access because it means: 
• development of new devices that make less-invasive treatments possible and bring new options to patients whose 
conditions would have been considered untreatable in the past, or when existing alternatives are unavailable, 
ineffective, or associated with substantial risks to patient safety 
• helping ensure patients have more options to treat or diagnose their disease or condition and potentially improve 
clinical outcomes, which is an important measure of safety 
• fostering innovation that spurs the development of safer, more effective technologies generally 
We do all of this while providing the assurances patients depend upon. The FDA’s work in this area has made 
dramatic differences to the millions of Americans whose lives have been saved or vastly improved by these 
technologies 
The U.S. has one of the highest regulatory standards for marketing authorization in the world – reasonable assurance 

 of safety and effectiveness – which serves us well in protecting public health. However, because it is one of the 
highest standards, more evidence is often needed to meet the U.S. standard, which can create, and has created, 
disincentives for developers of important new devices to seek access to the U.S. market early, if at all. This 
ultimately has a negative effect on patient health, thereby not promoting public health. Prior to 2010, the time gap 
continued to grow between when important technologies reached U.S. patients as compared to other developed 
countries putting U.S. patients at increasing risk. That said, the FDA does not believe, and has long stated publicly, 
that the solution to this problem is not to change the U.S. standard or to compromise the robust evidence on 
which we rely to approve devices. Instead, the FDA has been focused on taking steps to reduce the time and cost of 
the total product life cycle of medical devices, as appropriate, that do not compromise our standard of reasonable 
assurance of safety and effectiveness. Our goal is that innovators will view the U.S. marketplace more favorably, 
and bring safe and effective products to U.S. patients earlier than they have been. That would be a win-win for 
patients. 
 
ICIJ Q17: Does the FDA track the off-label use of devices? Should the FDA have an official reporting system 
for off-label use? 
FDA RESPONSE TO Q17: 
The FDA does not typically track off-label use of devices. The FDA may not regulate the practice of medicine as it 
pertains to the use of legally marketed devices, which includes the off-label use of devices by health care providers. 
With few exceptions, health care providers generally may choose to prescribe or use a legally marketed medical 
device for an unapproved or uncleared use when they judge that the unapproved use is medically appropriate for an 
individual patient. It is also important to note that the FDA, and even manufacturers, may not become aware of 
adverse events associated with the off-label use of a device because these events may not be reported by physicians 
and patients. 
That  said,  when  the  FDA  learns  of  serious  adverse  events  associated  with  off-label  use  of  a  medical  device,  it can 
and  has  alerted health care providers and patients of those concerns and provided clarification on using the device as 
intended  in  the  label.  Two  recent  examples  are  safety  communications  about  the  improper  use  of  rupture  of 
membranes  tests,  and  deceptive  health  claims  and  significant  risks  related  to  devices  marketed  for  use  in  medical 
procedures  for  “vaginal  rejuvenation.”  ​ICIJ  Q22:  What  is  the  FDA  doing  to  ensure  that  device  companies  are 
properly  filing  adverse  event  reports?  ICIJ  has  identified  thousands  of  reports  in  which  patients  died  that 
were reported as less serious incidents such as injuries and malfunctions. 
FDA RESPONSE TO Q22: 
The FDA has made it a priority and taken several actions in recent years to assure better and proper reporting of 
adverse event reports. 
The agency has taken several steps to improve the adverse event reporting process, including making it easier to 
report adverse events, both for industry and for patients, caregivers and consumers who submit voluntary reports. 
For example, in February 2014, the FDA issued the electronic Medical Device Reporting (eMDR) Final Rule and 
Guidance, which requires mandatory electronic reporting for manufacturers and importers. While the rule did not 
change what must be included in an MDR submission to the FDA, it facilitated more expedient and timely reporting 
by industry. The FDA worked closely with industry through the August 2015 implementation date to help them 
meet their eMDR reporting obligations. With eMDR reporting, the FDA received reports in a more expedited way 
when compared to mailing and processing the paper reports. With paper reporting, it took from three days to more 
than six months before an MDR submitted on a paper copy of the Form FDA 3500A was available for analysis in 
the FDA’s database. With a standardized electronic format, the majority of medical device reports are available for 
analysis within a day or two after submission to the FDA electronic submission gateway. Moreover, the option for 

 high volume reporting supports the batch submission of more than one individual MDR at a time. 
The  FDA  also  finalized  guidance  on  medical  device  reporting  for manufacturers in November 2016. The document 
organizes  and  makes  more  transparent  our  current  thinking  and  recommendations  on  medical  device  reporting  for 
manufacturers, which has evolved significantly since guidance on this topic was first issued in 1997. 
However, the FDA’s MDR analyses recognizes that some adverse events are not properly reported. In these cases, 
the FDA takes steps to correct the event type in these analyses. If adverse event reports are repeatedly received 
referencing the wrong type of event (e.g., references a malfunction when it should be a serious injury or death), the 
FDA contacts the manufacturer alerting them of the error in the submission and asks that they submit a supplemental 
report to correct the error. Since the eMDR rule became effective, the electronic supplemental reports received are 
publicly available soon after receipt. In the event that an FDA analyst becomes aware of an incorrect event type, 
they may take additional actions, which include correcting the event type in the internal database, or contacting the 
firm for additional information regarding the report submitted, as appropriate. The corrections made by the analyst 
are not available in the public database. Please note that the information that is publicly available is a reflection of 
what the FDA receives, and does not include FDA actions to analyze or correct information. This is why, as noted 
below, due to limitations of the current MDR system, conclusions about a device’s safety or role in an adverse event 
cannot be drawn from publicly available MDRs alone. We also note that sometimes an individual or entity may 
submit an adverse event as a death to the FDA, but upon further evaluation by the firm it is determined that the death 
was not the result of use of the device although the device may have malfunctioned or caused a less serious harm. In 
those cases, the report submitted to FDA should not identify the event as a device-related death. 
The FDA also conducts inspections to identify mis-reporting or incomplete reporting, and takes enforcement actions 
against manufacturers when appropriate. 
Medical device reporting is a key part of the FDA’s ongoing effort to detect and correct medical device problems in 
a timely manner, and these reports may contribute to the detection of potential device-related safety issues as well as 
to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of 
reporting system has notable limitations, including the potential submission of incomplete, inaccurate, untimely, 
unverified, or biased data. Confirming whether a device actually caused a specific event can be difficult based solely 
on information provided in a given report. Complaints or adverse event reports do not necessarily directly indicate a 
faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of 
event occurrence. Additionally, we may receive multiple reports related to the same event making it difficult to 
determine actual numbers of events. Therefore, conclusions about a device’s safety or role in an adverse event 
cannot be drawn from publicly available MDRs alone. 
It is important to note that MDRs submitted to the FDA are only one source we use to monitor marketed medical 
devices. Other sources the FDA uses include, but are not limited to, reports from our MedSun 
Hospital Network, data from mandated post-market studies (post-approval studies, 522 studies), clinical trials or 
data published in the scientific literature, epidemiological research including evaluation of administrative databases, 
health care claims data or registries, patient feedback, and inquiries or investigations from foreign government, 
federal or state health agencies 
The FDA believes, and has long stated, that the current passive system of post-market surveillance has limitations. 
We refer to you to responses on other questions detailing our work to establish an active surveillance system through 
NEST. 
In addition, if ICIJ and its partners believe that there are adverse event reports submitted to the FDA that have been 
incorrectly reported we urge the ICIJ and its partners to share that information with us so we can review to 
determine whether or not any or all of them have in fact been mis-reported, and, if so, follow up accordingly. 

  
ICIJ Q4. In recent years the FDA has used a concept called “acceptable uncertainty,” in which the agency 
puts devices on the market sooner and collects data about their safety and effectiveness afterwards. Does the 
FDA believe that its current system of post-market surveillance is capable of promptly and consistently 
identifying dangerous devices and enables the agency to protect public health? If so, why? 
FDA RESPONSE TO Q4 
We understand how critical it is for patients to continue to trust that the medical products the FDA reviews are safe 
and effective before they go on the market. But we can never have absolute certainty about all aspects of how a new 
product will perform. No reasonably sized premarket trial can ever be expected to reveal everything that could 
eventually become known about a medical product, particularly as it will not reflect the full spectrum of patients and 
providers who will use the product. This is reflected in the device regulatory standard enacted by Congress in that it 
requires a reasonable assurance, rather than absolute assurance, of safety and effectiveness. Therefore, the question 
is not whether there is uncertainty about the benefits and risks of a medical product but rather how much uncertainty 
is appropriate in a given case. 
In  addition,  federal  statute  requires  that  the  FDA  consider  whether  the  extent  of  data  that  otherwise  would  be 
required  for  approval  of  a  premarket  approval  application  with  respect  to  effectiveness  can  be  reduced  through 
reliance on post-market controls, e.g., post-market data collection. 
When we are dealing with a technology that is intended to address a life-threatening disease for which there is 
currently no treatment – a breakthrough device – it may be appropriate to accept a little more uncertainty in the 
pre-market context with a requirement to gather additional data in the post-market context, while still meeting the 
standards for marketing authorization. The breakthrough device provisions were enacted into federal law by 
Congress as part of the 21st Century Cures Act, and include a provision stating that the FDA may facilitate, when 
scientifically appropriate, expedited and efficient development and review of the device through utilization of timely 
post-market data collection with regard to a premarket approval application. However, because of challenges with 
conducting and completing post- market studies due to the lack of incentives for patients to enroll, we typically do 
not accept more uncertainty because we do not have adequate assurances the evidence needed to address the greater 
uncertainty will be generated. The FDA has issued draft guidance designed to make these considerations on 
uncertainty more transparent, consistent and objectively-defined for the review of medical devices. It provides a 
more rigorous, methodical and science-based approach for how the FDA considers uncertainty in benefit-risk 
determinations to support certain medical device premarket decisions that are based on the totality of the scientific 
evidence available at the time of market entry. More information about the draft guidance and background on the 
consideration of uncertainty is available here: 
https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm619414.htm  
The FDA has long stated that the current system of post-market surveillance has limitations in promptly and 
consistently identifying safety risks, a challenge that is not unique to the U.S. These limitations include relying on 
passive surveillance. This type of surveillance relies on certain entities becoming aware of an incident resulting in 
patient harm or likely to result in harm, determining that the incident was related to the use of a device, and then 
taking the time to report it to the FDA or the device manufacturer. As a result, many adverse events are not reported 
and we may not identify a new safety risk until after more patients have been unnecessarily exposed to a potentially 
harmful device. The FDA discussed these limitations and proposed the steps necessary to address them, including 
the creation of a national system, in a 2012 document titled, Strengthening our National System for Medical Device 
Postmarket Surveillance and, since then, in collaboration with other stakeholders, has led the effort to establish the 
National Evaluation System for health Technology (NEST). In our 2012 document, we proposed that the national 
system have active surveillance capabilities to complement our adverse event reporting (passive surveillance) 
system. Active surveillance involves actively and continuously generating, accessing, and evaluating large data sets 

 on device performance and clinical outcomes associated with device use in routine clinical practice. Active 
surveillance has the potential to empower stakeholders to make timelier, evidence-based decisions. 
To drive change toward an active system, under the statute, the FDA established and continues to implement the 
unique device identification (UDI) system, which will allow for more accurate reporting and analyzing of adverse 
events, and we have been helping to create new real-world data sources. In our April 2018 Medical Device Safety 
Action Plan, we proposed next steps for creating these capabilities, which we believe is now possible in light of the 
steps we have already taken. 
Ensuring the safety of medical devices on an ongoing basis is far more complex than having a vigilant post-market 
surveillance system for quick identification of new or increased safety signals. It requires the ability to conduct and 
complete post-market studies to determine if those signals represent a true risk to patients or are a false signal and 
timely public communication when there is a real safety issue. However, quickly identifying and addressing safety 
risks is only half the story. The FDA also believes it is important to foster innovation that spurs the development of 
safe and effective technologies that improve patient care or provide treatment where none exists. That’s why timely 
access is also important for public health. Patients are harmed by their underlying disease or condition. Timely 
access to safe and effective technology that addresses an unmet medical need or offers significant advantages over 
existing alternatives means less patient harm. We need both more effective post-market surveillance and device 
innovation to optimally improve the health and quality of life of patients and enable decision-making based on the 
best available evidence about medical devices. That is why the FDA has led the effort to establish NEST.  
 
ICIJ Q13: Dr. Shuren has discussed pushing some experimentation with new devices onto certain patient 
populations that are deemed to need access to experimental devices. Patient advocates warn that this 
approach could turn the general patient population into test subjects. How confident is the FDA that shifting 
some data from premarket approvals onto the postmarket will not put some patient populations in harm’s 
way? 
FDA RESPONSE TO Q13: 
The FDA generally and Dr. Shuren specifically have not been pushing experimental devices into the marketplace. 
We only provide marketing authorization for devices that meet the applicable statutory standards. In certain cases – 
for example, a breakthrough device – it may be appropriate to accept a little more uncertainty in the pre-market 
context with a requirement to gather additional data in the post-market context, while still meeting the standards for 
marketing authorization. The reasonable assurance of safety and effectiveness standard provides for this flexibility. 
Additionally, the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires the FDA to consider whether the 
extent of data that otherwise would be required for approval of a premarket approval application with respect to 
effectiveness can be reduced through reliance on postmarket controls. Companies must still provide the data 
required in the post-market phase to remain on the market, even when some data is not required at the time of 
approval. This provision in the law is intended to provide timely patient access while still assuring a device is safe 
and effective. Because patients often lack an incentive to enroll in clinical trials once a device has been approved, it 
can be challenging to conduct post-market studies. That has been a limitation with respect to this statutory provision 
and, when we do consider it appropriate to collect some data post-market rather than premarket, we typically limit 
what data we will permit for post-market collection. To address these limitations, we proposed a strategy in 2012 
and have since taken steps to establish the National Evaluation System for health Technology (NEST). We further 
describe NEST and the rationale behind it in our response to your Question 4 above. 
The FDA has recently issued draft guidance to make these considerations on when it is appropriate to accept greater 
uncertainty more transparent, consistent and objectively-defined for the review of medical devices. The guidance, 
released in September 2018, provides a more rigorous, methodical and science- based approach for how the FDA 

 considers uncertainty in benefit-risk determinations to support certain medical device pre-market decisions that are 
based on the totality of scientific evidence available at the time of market entry. This provides a more systematic 
approach to how we evaluate and address uncertainty while still ensuring patients are protected. 
Congress and many stakeholders, including patient groups, have long recognized the importance of facilitating 
access to devices, but still providing reasonable assurance that the device is safe and effective based on the totality 
of the evidence, when there is a public health need, such as for those patients with life-threatening diseases who 
have few to no alternatives on the market. Moreover, the approach in the draft guidance is consistent with section 
515B(e)(2)(C) of the FD&C Act, which was added by the 21st Century Cures Act, in which Congress required the 
FDA to “facilitate, when scientifically appropriate, expedited and efficient development and review of the device 
through utilization of timely post-market data collection with regard to application for approval” -- for breakthrough 
devices. Organizations such as the National Organization for Rare Disorders (NORD)2 and the Infectious Disease 
Society of America3 supported inclusion of this provision and organizations including the Juvenile Diabetes 
Research Foundation (JDRF) supports the FDA’s breakthrough devices program in general as, when appropriate, it 
helps patients have access to safe and effective medical devices earlier when they may not have other options (or 
existing options are not helpful). Again, see our response to Q4 for more information about “acceptable 
uncertainty.”  
 
ICIJ Q8. How are recalls and warnings communicated between the FDA and its counterparts overseas? How 
does the FDA evaluate warnings or recalls issued first overseas? 
FDA RESPONSE TO Q8 
Information the FDA obtains regarding overseas warnings and recalls is considered along with all of the information 
the FDA has available when considering the public health impact. Warnings or recalls issued first overseas may not 
pertain to devices marketed in the U.S. When they are, the FDA typically follows up to better understand the basis 
for the action and whether additional action by the FDA is warranted. 
The FDA engages heavily with our international counterparts to share information about potential safety concerns 
with medical devices, and to identify and take action to protect patients and the public health where possible. The 
FDA has confidentiality commitments with numerous regulators around the world. With those countries that we 
have confidentiality commitments in place, we often exchange information about potential safety issues, including 
recalls and warnings initiated either in the U.S. or abroad, and have discussions about those issues. In addition, 
under a program created through the International Medical Device Regulators Forum, the National Competent 
Authorities Report exchange program is one mechanism used to exchange information related to reportable events 
or potential trends that individual regulators have observed in their jurisdictions, but have not yet resulted in recalls 
or warnings. This program includes a total of 23 countries (including the U.S.) and the EU. 
 
 
ICIJ Q1: Most new products allowed on the market by the FDA are cleared through a substantial 
equivalence pathway, such as the 510(k) process. Some of these devices include new technology not subjected 
to clinical trials. How do you ensure that patients are protected from unanticipated harms that can result 
​1 https://rarediseases.org/wp-content/uploads/2015/06/NORD-Comments-on-the-21st-Century-Cures-Act.pdf
2 https://webcache.googleusercontent.com/search?q=cache:OQBerB9laAJ:https://www.idsociety.org/uploadedFiles/IDSA/Policy_and_Advocacy/Current_Topics_and_Issues/
Antimicr
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vations%25 20White%2520Paper%2520021915.pdf+&cd=4&hl=en&ct=clnk&gl=us&client=firefox-b-1-ab
2
3

 from these devices? Should the FDA require more devices to go through pre-market approval? 
FDA RESPONSE TO Q1: Several of the premises included in your question are incorrect. For instance, most 510(k) 
devices are not truly new products, all 510(k)-cleared devices have been determined to be substantially equivalent to 
a legally marketed predicate device, 510(k) submissions may require extensive testing, and in some cases 510(k) 
submissions must include clinical trials when it is necessary to demonstrate the device is at least as safe and 
effective as the predicate device. 
The FDA’s device program is risk-based, which means devices that pose the highest risks to patients have the most 
rigorous requirements before they can be marketed. This system was set up by Congress to ensure patients are as 
best protected as possible from risks, while also enabling timely access to safe and effective medical devices, 
consistent with the FDA’s mission to both protect and promote public health. 
Generally, new technology is subject to a pre-market approval application (PMA) when it is high risk and subject to 
the de novo pathway when it is lower risk. The 510(k) pathway is typically available for lower risk devices for 
which one or more similar technologies are already on the market, not for truly “new products” as stated in the 
question above. 
The FDA may require extensive testing for devices subject to a 510(k), generally requiring more evidence for more 
complex technologies. Because most devices, unlike drugs, are hardware and have localized effects on the body, 
robust non-clinical testing can demonstrate that a device performs similarly to comparable devices already on the 
market and that its benefits outweigh its risks. And we can often get this information without subjecting patients to 
clinical trials. For example, for some devices, such as syringes and infusion sets, bench testing – for 
biocompatibility, and mechanical and physical performance tests – can provide the information the FDA needs to 
determine that these devices are safe and effective for patients. For others, such as some bone void fillers or 
substitutes, animal studies provide information in cases where histology and destructive testing cannot be done on 
humans. And, when appropriate, we do require clinical studies for certain devices subject to a 510(k). 
PMA is the most rigorous type of device marketing application required by the FDA, and is appropriate for higher 
risk devices where general and special controls are not sufficient to provide reasonable assurance of safety and 
effectiveness of the device. However, the PMA pathway is not appropriate for all medical devices. Requiring a PMA 
for lower risk devices that are similar to other devices already on the market – those eligible for a 510(k) – would 
not necessarily provide better patient safeguards, but would result in unnecessary costs and delays while diverting 
FDA staff resources away from studying and evaluating higher-risk and novel devices. 
However, if based on new information, we determine that a device type should no longer be eligible for the 510(k) 
pathway, such as due to a significant safety concern, we can and have reclassified these devices into class III and 
required submission of a PMA. In the past few years, the FDA has been more active in using this authority. Since 
Congress enacted the Medical Device Amendments in 1976, the FDA has eliminated the use of 1,758 devices 
subject to a 510(k) as predicates through reclassification into class III, 84 percent (1,477/1,761) of which were 
eliminated between 2009 and the present; we eliminated roughly six times more devices as predicates in the past 10 
years than in the prior 30 years of the program (1,477 vs 219). This is not because newer 510(k) devices are less 
safe. To the contrary, most device types we have reclassified into class III are older technologies. 
We also do establish higher thresholds for the data required to market certain 510(k) devices when we believe the 
510(k) remains the appropriate pathway but also determine that requiring new or additional testing would best 
protect patients. For the past few years, the FDA has made a concerted effort to assure we require the appropriate 
level of testing, including raising the bar when appropriate, such as in the case of infusion pumps. Because of these 
efforts, since 2009 the average page count of a 510(k) submission more than doubled to more than 1,100 pages. 
While industry has raised concerns about these increased demands, we believe additional information for certain 
applications is necessary and in the best interests of patient safety. Where we believe there is insufficient evidence to 
support the safety and effectiveness of a device type, we will reclassify those devices into Class III, which we have 

 done on several occasions. For more information, see our response to Question 15. 
While  510(k)  devices  have  become  more  complex  given  scientific  advances,  we  have  not seen the risks from these 
devices  increased.  In  fact,  only  1  percent  of  510(k)  devices  are  subject  to  a  recall  annually;  a  recall  being  any 
correction  made  to  a  device,  including  labeling  changes  and  user  training.  That  number  has  remained  relatively 
steady for more than a decade. 
Regardless of the type of submission – 510(k), PMA, or de novo – FDA requires a reasonable assurance of safety 
and effectiveness of the device before it can be marketed. FDA has demonstrated its willingness to require more data 
or reclassify devices when necessary to protect patients, as further explained in our response to Question 15. 

 
 
ICIJ Q15: What is the FDA’s legal authority to rescind the 510k of a dangerous, defective or ineffective 
device? How many 510ks has the FDA rescinded? Relatedly, what is the FDA’s authority to block 
manufacturers from referencing the 510k of a defective or dangerous device as a predicate in new device 
applications? How many 510ks has the FDA blocked from serving as a predicate? Please provide specific 
examples. 
FDA RESPONSE TO Q15: 
Based on the decision of the United States Court of Appeals for the D.C. Circuit in Ivy Sports Medicine, LLC v. 
Burwell, 767 F.3d 81 (D.C. Cir. 2014), the FDA’s authority to rescind 510(k) clearances is more narrow than the 
agency had traditionally interpreted it to be. However, the FDA maintains that it has authority to rescind a clearance 
decision in certain circumstances such as where there is fraud or misconduct. Within the past 15 years, the FDA has 
rescinded approximately 40 510(k)s. 
The FDA will take action to eliminate the use of a 510(k) cleared device as a predicate when it raises safety 
concerns. For example, the FDA may pursue reclassification (from Class II to Class III) and issue a call for 
Premarket Approval Applications (PMA) when the agency has determined that a device type should be regulated as 
high risk because general and special controls are not sufficient to assure its safety and effectiveness. This process 
eliminates the use of previously cleared 510(k)s as legal predicates. 
Since Congress enacted the Medical Device Amendments in 1976, the FDA has eliminated the use of 1,758 devices 
as predicates in the 510(k) process. Of these, 1,477 (84 percent) have been eliminated since 2012. We have 
eliminated roughly six times more devices as predicates in the past 10 years than in the prior 30 years of the 
program. This is not because newer 510(k) devices are less safe. To the contrary, most device types we have 
reclassified into class III are older technologies. 
Specific examples include the elimination of previously cleared 510(k)s for vaginal mesh for the treatment of pelvic 
organ prolapse, automated external defibrillators and metal-on-metal hip implants. 
Although the FDA must clear devices that are shown to be substantially equivalent to predicates, the FDA will take 
other actions when a device raises safety concerns. For example, the FDA may determine that the product under 
review is substantially equivalent but misbranded or adulterated, meaning the company cannot lawfully market the 
device. Typically, we do not have to issue such a decision because companies generally will fix the product under 
review to address the safety concern and be able to lawfully market their product. This is an infrequent occurrence 
for the roughly 3,500 510(k) submissions we receive annually on average. In addition, when a device that could be 
used as a predicate raises safety concerns, we will take steps to have those concerns satisfactorily addressed or have 
the device removed from the market. Voluntary recalls are used in the vast majority of these cases and almost 
always result in a faster action to remove or correct devices than the mandatory recall process. The FDA’s 

 experience is overwhelmingly that companies will voluntarily correct the problems—either on their own or at the 
FDA’s request—to ensure that the proposed device can be placed on the market or the predicate device can remain 
on the market. 
 
ICIJ Q10. What are the rules and processes for medical devices manufactured by US companies
and approved for “export only”?
FDA RESPONSE TO Q10
Medical devices designated as “export only” and that do not comply with the Federal Food, Drug, and Cosmetic Act 
(the Act) cannot be marketed in the U.S. but can be exported if certain requirements are met. 
Some devices (generally Class I or II) can be exported as “export only” devices if they meet the criteria outlined in 
Section 801(e)(1) of the Act: they must be in compliance with the specifications of the foreign purchaser, not in 
conflict with the laws of the nation to which they are intended for export, labeled that they are intended for export, 
and not be sold or offered for sale in the U.S. 
Other devices must meet additional requirements to be exported, such as Class III devices, investigational devices 
and banned devices. Such devices could be exported if they qualify under section 802 of the Act. For example, 
under one of the section 802 pathways, devices may be exported if, among others, they have a valid marketing 
authorization from one of the listed countries (Australia, Canada, Israel, Japan, New Zealand, Switzerland, South 
Africa, a member of the European Union, or the European Economic Area), and are in substantial compliance with 
the FDA’s good manufacturing practices (GMPs). In addition, the device must be in compliance with the 
specifications of the foreign purchaser, not in conflict with the laws of the nation to which they are intended for 
export, labeled that they are intended for export, and not be sold or offered for sale in the U.S. 
Exporting a class III device under section 802 does not require prior approval from the FDA; instead, the exporter 
must submit a “simple notification” to the FDA, identifying the product’s trade name, type of device, product’s 
model number and the country that is to receive the exported article if the export is to one of the countries that is not 
listed above. Alternatively, such devices qualify for export via a different pathway under section 801(e)(2) if the 
company provides information to the FDA for a determination that the exportation of the device is not contrary to 
public health and safety and that the device has the approval of the country to which it is intended to be exported. In 
addition, the device must be in compliance with the specifications of the foreign purchaser, not in conflict with the 
laws of the nation to which they are intended for export, labeled that they are intended for export, and not be sold or 
offered for sale in the U.S.