FDA's Draft Guidance Pediatric Uses of Medical Devices

Sunday, March 2, 2014 10:36:45 AM Europe/Berlin

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

Posted By QM-Docs

FDA's Pre-Sub replaces pre-IDE

Sunday, March 2, 2014 10:25:47 AM Europe/Berlin

Established in 1995, the pre-IDE program has been a successful resource for both medical device applicants and FDA and has become the most commonly used mechanism for requesting FDA’s feedback prior to a premarket device submission.

Intentially, this program was designed to provide applicants a tool to obtain FDA feedback on planed IDE applications prior to their submission. This new guidance ioncludes a broader scope of the program.


See --> Requests for Feedback on Medical Device Submissions. The Pre-Submission Program and Meetings with FDA

Posted By QM-Docs