The Food and Drug Administration announces a Public Meeting, titled “Pediatric Medical Device Development,” to be held Aug. 13-14, from 9:00 a.m. to 5:00 p.m. EST, at the FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31, Room 1503 (the Great Room) in Silver Spring, MD.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations. However, medical device development for children continues to lag behind that for adults, according to FDA. As such, the purpose of the meeting is to identify strategies that enhance the medical device ecosystem toward development and innovation of devices that serve the complex needs of children, and thereby accelerate medical device innovation for all Americans.
As outlined in the Food and Drug Administration Reauthorization Act (FDARA) of 2017, the meeting shall include consideration of ways to:
- improve research infrastructure and research networks to facilitate the conduct of clinical studies of pediatric devices; (improve research infrastructure and research networks);
- appropriately use extrapolation under section 515A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(b)); (appropriate use of extrapolation);
- enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling; (appropriate use of postmarket registries);
- increase FDA assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use;
- increase FDA assistance to pediatric device developers; and
- identify current barriers to pediatric device development and incentives to address such barriers. (identify current barriers and incentives).
FDA invites all stakeholders, including representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007 (Public Law 110–85; 42 U.S.C. 282 note), medical provider organizations, and organizations and individuals representing patients and consumers to collaborate with us in addressing this important public health issue.
Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. If you wish to attend this meeting, you must register by 4:00 p.m. on August 6, 2018. There is no fee to register, which will be handled on a first come, first served basis. Early registration is recommended because seating is limited.
For more information, and to register for the meeting, click here.