FDA to Hold Pediatric Medical Device Development Public Meeting August 13-14
On August 13 and 14 the Food and Drug Administration (FDA) will be holding a public meeting on “Pediatric Medical Device Development.” The meeting will be held at the FDA White Oak Campus in Silver Spring, MD, and will also be available to live stream via webinar. Registration is required for both in-person and webinar attendance.
The primary goal of the meeting is to identify strategies to improve the infrastructure surrounding the development and innovation of pediatric medical devices and will include consideration of ways to:
- Improve research infrastructure and research networks to facilitate the conduct of clinical studies of pediatric devices;
- Appropriately use extrapolation under section 515A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(b));
- Enhance the appropriate use of post market registries and data to increase pediatric medical device labeling;
- Increase FDA assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use;
- Identify current barriers to pediatric device development and incentives to address such barriers.
For more information and to register for this event, click here: https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm596777.htm