Providing Information About Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Providing Information about Pediatric Uses of Medical Devices." FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).