Reclassification Petitions for Medical Devices

This information collection helps to implement section 515 (21 U.S.C. 360e) of the Federal Food, Drug, and Cosmetic Act, with regard to the reclassification of medical devices. Section 515 provides, among other things, that, upon petition, a manufacturer may request that FDA reclassify a medical device. Accordingly, we have established reclassification procedures consistent with statutory requirements that set forth format and content elements.

The latest form for Reclassification Petitions for Medical Devices expires 2028-07-31 and can be found here.