Device Documents

Manufacturers of devices believed to be non-critical and substantially equivalent to devices manufactured prior to 1976 may submit a pre-market notification outlining device specifications and characteristics. These notifications, usually called 510(k)s because they are regulated by section 510(k) of the Medical Device Amendments, are reviewed by the FDA. If, after review, the FDA agrees with the manufacturer's determination, the device can be marketed. Substantial portions of the 510(k) are available through FOIA once an Agency decision has been reached.

Since 1976, over 76,000 510(k)s have been cleared for marketing. Although substantial portions of the 510(k) are available using the Freedom of Information Act, there is often an 18 to 24 month backlog in FDA's processing time for these requests. With over 35,000 510(k)s on file, FOI Services can often provide a 510(k) immediately.

Devices determined to be new and/or life supporting or otherwise critical are subject to the pre-market approval (PMA) requirements. Similar to a new drug approval, the PMA must document the device's safety and effectiveness through pre-clinical and clinical testing. The PMA undergoes scientific review by appropriate FDA personnel and advisory committees. Because of the volume of confidential business and patient information in a PMA, it is not disclosable under FOIA. Instead, a Summary of Safety and Efficacy (SS&E) is prepared and available along with the approval letter and labeling.