Info Collection Revision on PMA Submissions

Federal Register notice: FDA is seeking comments on an information collection revision entitled “Premarket Approval of Medical Devices.” The collection is being revised to include the burden associated with recommendations related to the guidance entitled “Providing Information about Pediatric Uses of Medical Devices.” It is also being revised related to information submission on device pediatric uses under section 515A of the FD&C Act, which requires applicants to include readily available information providing a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients. This information allows FDA to track the number of approved devices for which there is a pediatric subpopulation that suffers from the disease. To view the notice, click here.