u.s. FOOD DRUG ADMINISTRATION October 12, 2018 UC San Diego Nicole Le Research Data Analyst 16918 Dove Canyon Road Suite 100 San Diego, California 92127 Re: Ql 81276 - Study Determination for the Proposed Study titled, Randomized Blinded Sham- controlled Phase II Study of Personalized Repetitive Transcranial Magnetic Stimulation for Adult Patients with a History of Chemotherapy-induced Cognitive Impairment, Trade/Device Name: MagVenture MagPro R30 transcranial stimulator Received: July 16, 2018 Dear Ms. Le: An IDE application is not required to be submitted to, or approved by, FDA for a NSR study. A NSR study is, however, subject to the abbreviated requirements described in 812.2(b) of the IDE regulation. The abbreviated requirements stipulate that the sponsor of the investigation must label the device in accordance with 812.5; obtain institutional review board approval of the investlgation as a NSR study; ensure that each investigator obtains informed consent from each subject under the 1nvestigator's care; comply with the monitoring requirements of 812.46; maintain records required under and (5) and ?le the reports required under through (3) and (5) through and ensure that participating investigators maintain the records required by and ?le the reports required under (2), (5) and (7). Under the abbreviated IDE requirements, a sponsor must also comply with the prohibitions against promotion and other practices as identi?ed in 812.7. According to this section of the regulation, the sponsor of a NSR study, investigator, or any person acting for or on behalf of the sponsor or investigator is prohibited from promoting or test marketing the investigational device until after FDA has approved the device for commercial distribution; commercializing the device by charging a price greater than that necessary to recover the cost of manufacture, research, development, and handling; unduly prolonging the U.S. Food Drug 10903 New Hampshire Avenue Silver Spring, MD 20993 Page 2 - Nicole Le Q181276 investigation; and representing the investigational device as being safe or effective for the purposes for which it is being investigated. If this study may be used to support a future marketing application, we recommend that you submit a pre- submission to obtain our feedback on the clinical protocol. More information can be found in the guidance document, ?Requests for Feedback on Medical Device Submissions: The Pre- Submission Program and Meetings with Food and Drug Administration Staff? 1 l76.pdf). Title of amended the Public Health Service Act (PHS Act) by adding new section 4020) (42 USC 2820)), which expanded the current database known as ClinicalTrials. gov to include mandatory registration and reporting of results for applicable clinical trials of human drugs (including biological products) and devices. Please note that, if in the ?iture you submit an application under sections 505, 515, or 520(m) ofthe FDCA (21 USC 355, 360(6), or 3600)(m)), or under section 351 ofthe PHS Act (21 USC. 262), or you submit a report under section 510(k) of the DCA (21 USC 360(k)), the application or submission must be accompanied by a certi?cation that all applicable requirements of section 4020) of the PHS Act (42 USC 2820)) have been met. Where available, such certi?cation must include the appropriate National Clinical Trial (NCT) control numbers. 42 USC Additional information regarding the certi?cation is available at: 64819.pdf. Additional information regarding Title of is available at: Additional information on registering your clinical trial(s) is available at the Protocol Registration System website If you have any questions, please contact Kristen Bowsher, at 301 -796?6448 or Kristen.Bowsher@fda.hhs.gov. Sincerely, Carlos L. Pena -S Carlos L. Pe?a, MS Director Division of Neurological and Physical Medicine Devices Of?ce of Device Evaluation Center for Devices and Radiological Health