The Food and Drug Administration (FDA) is issuing a final rule amending the

regulations on premarket approval of medical devices to include requirements relating to the

submission of information on pediatric subpopulations that suffer from the disease or condition that

a device is intended to treat, diagnose, or cure.

 

See --> Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act