DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Admin istra ti on 1090 3 New Ham pshire Avenue Silver Spring , MD 209 93 It Ha s Come to Our Attention Letter Dr. James Versalovic Texas Children 's Hospital 11 02 Bates Avenue Su ite 830 Houston , TX 77030 jamesv@bcm .edu March 2 , 2016 Dr. James M. Musser Houston Methodist Hospital 6565 Fannin Street Houston , TX 77030 jmmusser@houstonmethodist.org Document Number: GEN16001 09 Dear Dr. Versalovic and Dr. Musser: It has come to our attention that you are currently marketing the Zika Direct Test , which is intended to be used as a rap id diagnostic test to identify virus-specific RNA sequences to directly detect Zika virus . The Direct Zika Test appears to meet the definition of a device as that te rm is defined in section 201 (h) of the Federa l Food Drug and Cosmetic Act. Based on our review of your promotional materials , we believe you are offering a high risk test that has not been the subject of premarket clea rance , approval , or Eme rgency Use Authorization review by the Food and Drug Adm inistration (FDA). The FDA would like to better unde rstand the test's design , validation and performance characteristics , and in addition , CDC and CMS have asked us to review the science beh ind your tes t. We believe that due to the curren t public health emergency it is appropriate fo r the Food and Drug Adminis tration to review information related to the development of the test. We have assigned a unique documen t numbe r tha t is cited above . T he requested information should reference this document number and should be submitted to : James L. Woods , W066-4684 Deputy Director Patient Safety and Product Quality Office of In Vitro Diagnosti cs and Rad iological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 Dr. James Versalovic, Texas Children's Hospital Dr. James M. Musser, Houston Methodist Hospital We look forward to discussing this with you, and are committed to working with you as we strive to protect the public health. Please contact us within seven (7) days to schedule a meeting. If you have questions relating to this matter, please feel free to call Patricia Spillar at 301-796-6191. Sincerely yours, Donald J. St Pierre -A for James L. Woods Deputy Director Patient Safety And Product Quality Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health 2