In a new 47-page guidance the FDA appears to be doing its best to cover the waterfront for medical device manufacturers who need to better understand the complex Medical Device Reporting (MDR) requirements. Topics range from the big picture (who is subject to this rule) down to specifics (how many times must a manufacturer call a user facility for information before it can close the file).
In a perfect world, the FDA would pick an intelligent, telegenic representative and provide this information in a live Q&A format with follow-up questions from the audience. Until that day, we’ve got to rely on the new guidance, published July 9, 2013.
MDR is FDA’s mechanism to work with medical device companies to identify and monitor adverse events, with an eye to detecting and correcting problems as quickly as possible.
Medical device makers are required to report when one of its devices may have or could contribute to a death or serious injury. Device makers have between five and 30 days to report, depending on the severity of the potential adverse event.
We won’t try to summarize the entire document here. Instead, we’ll highlight some of the more interesting FDA “answers” to its questions.
- How should you handle a voluntary report when you don’t know the source of it? FDA says to first evaluate the complaint to see if it is a reportable event. Base that determination on in-house information, and consider contacting a user facility, importer or other initial reporter related to the alleged event. “Your decision about whether or not the event is an MDR reportable event should be based on the findings of your evaluation,” the agency says.
- What is a ‘remedial action,’ and are those reportable to FDA and included as part of the more urgent 5-day report? The short answer is yes. FDA wants medical device manufacturers to attack problems with a wide lens. “FDA does not consider an action taken to correct only a single device involved in an MDR reportable vent to be a remedial action.” In other words, don’t forget CAPA and root cause analysis.
- What does FDA require for developing, maintaining, and implementing written MDR procedures? FDA says medical device manufacturers must include internal systems that provide for: timely and effective identification, communication, and evaluation of events; a standardized review process or procedure; and timely transmission of complete reports to the FDA.
- What information contained in an MDR report is subject to public disclosure. The bad news: All of it. The good news: FDA, before releasing a MDR report subject to a Freedom of Information Act request, will delete information covering trade secrets, personal medical information, and names and other identifying information of a third party that voluntarily submits a report, e.g., physicians and other health care professionals.
Comments are due in early October. Submit them to www.regulations.gov. Include the docket number (1828) with comments. Short URL for the draft guidance document: https://federalregister.gov/a/2013-16395