The classification of a medical device can change as more information is gathered about the device.  In order to have a device reclassified to a lower class, the device manufacturer must prove to the U.S. Food and Drug Administration (FDA) that lower class requirements will provide adequate safety and effectiveness through a petition.   On December 24, 2014, FDA amended the Food, Drug, and Cosmetic Act (FD&C Act) to reflect new mailing addresses for reclassification petition submissions.

 

If the device is regulated by the Center for Devices and Radiological Health, the petition should be mailed to:

Food and Drug Administration, Center for Devices and Radiological Health, Regulations Staff

10903 New Hampshire Ave., Bldg. 66, Rm. 4438

Silver Spring, MD 20993-0002

 

If the device is regulated by the Center for Biologics Evaluation and Research, the petition should be mailed to:

Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center

10903 New Hampshire Ave., Bldg. 71, Rm. G112

Silver Spring, MD 20993-0002

 

The address for petitions of devices regulated by the Center for Drug Evaluation and Research remains unchanged.  Petitions should continue to be mailed to:

Food and Drug Administration, Center for Drug Evaluation and Research, Central Document Control Room

5901-B Ammendale Rd.

Beltsville, MD 20705-1266

 

For assistance with a reclassification petition or other FDA regulations for medical devices, contact Registrar Corp.