FDA will be taking applications starting Sept 1, 2015, looking for makers of class I and suitable class II medical devices to participate in a pilot program to file malfunction reports in summary form quarterly. Get on the stick, though, if you are interested: there are only nine slots.
Under FDA’s Medical Device Reporting on Malfunctions, the agency hopes to streamline some reporting procedures. It wants any reports to include a “narrative text” with sufficient detail for a reviewer to understand what happened. The agency also expects to hear about subsequent investigations and corrective actions as necessary to address the situation(s).
There’s a carrot, too: manufacturers accepted into the pilot will be granted an exemption or variance from, or alternative to, the usual reporting requirements under 803.5 and 803.52 for covered devices. Accepted candidates can withdraw from the pilot program at any time. FDA can drop participants, too.
Pilot participants will be expected to submit FDA 3500A forms that cover a summary of malfunction events tied to a unique device problem code or set of codes within the quarterly timeframe, and for a particular device model number and/or catalog numbers.
The program was announced via an August 18 notice in the Federal Register. For more information, contact William C. Malone, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3236, Silver Spring, MD 20993-0002, email@example.com.