On Nov. 8, the FDA finalized its 2013 draft guidance on the Medical Device Reporting (MDR) regulation.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.

Under the MDR regulation, “MDR reportable events” are events that manufacturers “become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.” The final guidance breaks down the elements of this obligation, closely tracking the language in the MDR regulation. For example, the guidance specifies that a medical device may be considered to have “caused or contributed” to a death or serious injury, or to have been a factor, as a result of device failure, malfunction, improper or inadequate design, manufacture, labeling or user error. Additionally, section 2.14 explains the types of malfunctions the FDA considers reportable as MDRs and provides an explanation of devices it considers “similar” for purposes of reporting malfunctions.

Overall, the FDA’s final guidance differs very little from the draft released in 2013. Substantively, the only change appears to be in section 2.15, addressing how a manufacturer should decide whether a malfunction is “likely to” cause or contribute to a death or serious injury. The 1997 guidance had stated that if a malfunction did not cause or contribute to any deaths or serious injuries for 2 years, the presumption of future occurrences doing so was lifted. The draft guidance appeared to abandon this “2-year rule.” In the final guidance, however, FDA recommends that manufacturers submit “a notification to FDA with a summary of the data and the rationale for your decision to cease reporting at the end of 2 years.” Alternatively, manufacturers may “request an exemption under 21 CFR 803.19(d) from further reporting sooner than 2 years” if their analysis of the data supports such an exemption.

Other key provisions of the guidance include sections 2.17, 2.32 and 4.7.1, which address assigning MDR responsibility between two entities, and sections 2.23, 3.1 and 4.9.1, which expand on the good faith efforts manufacturers must make to obtain information about reported events. Section 3 of the guidance relates to written procedures, recordkeeping and public disclosure, and section 4 addresses specific issues and situations, including delays in surgery, the expected life of the device, device labeling, differences of medical opinion, foreign events, medical intervention and reports based on literature.

The FDA stresses in the final guidance that companies should “develop, maintain and implement” written MDR procedures, which must describe how the manufacturer conducts its own investigations of events that may be reportable. Additionally, manufacturers must establish and maintain — for 2 years from the date of the event or a period equivalent to the expected life of the device, whichever is greater — complete MDR files. The FDA will hold a webinar on Nov. 30 to help manufacturers understand these obligations and the information provided in the final guidance document. The webinar will take place from 1 p.m. to 2:30 pm EST, and no registration is required.