Medical Device Reporting
January 5, 2018 | Healthcare Risk, Quality, & Safety Guidance
MDR is intended to help FDA identify medical device problems that pose a threat to public health and safety. As established by SMDA in 1990 and modified by FDAMA in 1997, user facilities, including healthcare facilities, are required to report to FDA and/or the device manufacturer certain adverse events involving medical devices. Device-related incidents that must be reported include deaths and serious injuries and illnesses.
Failure to comply with FDA MDR requirements can result in substantial penalties for healthcare facilities. FDA has the authority to enforce its user reporting requirements through a number of mechanisms. The failure to report or the submission of false or misleading information could subject the user facility to a civil injunction or criminal prosecution. These remedies are not mutually exclusive and may be combined. The failure to comply can result in civil money penalties of $15,000 for each violation, up to a maximum of $1 million for all violations adjudicated in a single proceeding. Civil money penalties can be imposed only if there has been a “significant or knowing departure" from the MDR requirements or if there is a “risk to public health." (21 CFR 803; FDA “Medical . . . User")
In an October 24, 2016, blog post, Jeffrey Shuren, MD, JD, Director of FDA's Center for Devices and Radiological Health, stated FDA's desire to improve the way it works with hospitals “to modernize and streamline data collection about medical devices. " In light of several high-profile medical device cases that had emerged in recent years, FDA installed inspectors at 17 hospitals and found, among other issues, that hospital staff often were unaware of and not trained to comply with all of FDA's medical device reporting requirements. (Shuren)