Reclassification Petitions for Medical Devices

This ICR collects information from medical device manufactures who wish to request reclassification of a medical device. A manufacturer may petition the Agency to reclassify a device. The reclassification procedures regulation requires a manufacturer to submit specific data when petitioning for reclassification. This includes both a "supplemental data sheet" (Form FDA 3427) and a "classification questionnaire" (Form FDA 3429). Each of these forms contains a series of questions concerning the safety and effectiveness of the device type. The regulation requires device manufacturers to provide, in a petition for device reclassification, specification of the type of device, a statement of the action requested, and a justification for the request to reclassify.

The latest form for Reclassification Petitions for Medical Devices expires 2022-02-28 and can be found here.