Attention device manufacturers: Would you like the FDA to know more about your technology as it is being developed?
April 11, 2016 is the deadline to apply for the FDA’s Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP). ELP is an educational program designed to provide review staff with real-world knowledge of existing and emerging technologies. Because of the rapid pace in which medical device technology evolves, it is essential that CDRH reviewers understand how devices are developed, clinically ed, manufactured, and utilized.
The ELP program is designed to address knowledge gaps and help reviewers better understand innovative devices. Since 2012, nearly 1,000 CDRH employees have participated in more than 80 visits at over 60 sites. The program provides CDRH staff with an opportunity to observe the device development life cycle and provide a better understanding of the medical devices that are reviewed.
The Federal Register Notice describes CDRH’s areas of interest, the types of facilities they are seeking, and the process for applying. Submit either an electronic or written request. Requests must include the Docket Number FDA-2015-N-0986-0064.
Submit electronically at http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852.