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FDA Update: Final Guidance on Medical Device Reporting

FDA has issued final guidance on Medical Device Reporting (MDR) for Manufacturers. The goal of the guidance, says FDA, is to detect and correct device problems in a timely manner. This final guidance was issued on November 8, 2016. The draft of this document was issued on July 9, 2013. This latest document supersedes “Medical Device Reporting for Manufacturers,” dated March 1997. 

This guidance document describes and explains FDA’s current regulation that addresses reporting and recordkeeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions. What’s new since the 1997 document? Clarification on a few topics. For your convenience, here is where you can find some of them within the 46-page guidance. (Specifically, these are items that were called out in FDA’s webinar about the new guidance. Page numbers shown below correlate to the Table of Contents for the final guidance document.)

  • When a firm “becomes aware” that an MDR reportable event has occurred (Section 2.3, page 6)
  • MDR submission rules involving a marketed device that is being studied under an Investigational Device
    Exemption (Section 4.10.1, page 31)
  • MDR submission rules involving adverse events that occur ex-U.S. (Section 4.11, beginning on page 31;
    see Exhibit 1 below for summary)
  • Are you a contract manufacturer? Here is the exemption request process for MDR reporting for you
    (Section 2.17, page 14; see also Section 2.17 for detailed instructions on what to include)
  • The submission of 5-day reports and remedial actions (Sections 2.20 and 2.21, page 16)
  • The 2-year presumption for reportable malfunctions (Section 2.15, page 20)

Orthopaedics is called out in Section 4, Specific Issues and Situations. Here is the text:

4.2.4 Am I required to report routine explants of implanted devices that have an expected life that is less than the life of the patient, such as tissue valves, vascular grafts, or routine revisions of orthopedic implants?


Certain implanted devices have a specified “end of life” date. If the implant has reached or is near the end of its established life expectancy, and is subsequently replaced without a device-related death or serious injury associated with the replacement, then it would not constitute a reportable event, even if surgery is involved. However, the event would be reportable if the device caused or contributed to or may have caused or contributed to a patient death or serious injury, or malfunctioned and the malfunction of the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if it were to recur.  

Exhibit 1: MDR Submission Rules for Adverse Events that Occur Outside of the U.S.
If a foreign adverse event occurs, this chart specifies the MDR reporting obligation of the foreign event.

  Firm is located:   Market Status in U.S.   Market Status Ex-U.S.   Report a Foreign Event?
  U.S.   No   Yes   Yes, when requested
  U.S.   Yes   Yes   Yes
  Ex-U.S.   Yes   Yes   Yes
  Ex-U.S.  Under Study   Yes   Yes, only if a similar device
  marketed in the U.S. by the
  same manufacturer

Source: FDA/CDRH Webinar, November 30, 2016

Documents from FDA’s webinar on Medical Device Reporting for Manufacturers are available online, and include a recast of the presentation with slides, printable slides and a transcript of the presentation including Q&A at the end.