FDA releases final guidance on medical device reporting for manufacturers

From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.On Nov. 8, the FDA finalized its 2013 draft guidance on the Medical Device Reporting (MDR) regulation. The guidance supersedes the FDA’s previous 1997 guidance document and addresses the reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions. While the guidance is intended for only medical device manufacturers, it may also be of interest to medical device user facilities, importers of medical devices and medical device distributors, which are also subject to the adverse event reporting and recordkeeping requirements.