Further to our previous blog entry, we can now provide additional analysis of the new MDR Reporting guidance issued by the FDA last week. You can find a link to the guidancehere.
The draft guidance takes a question/answer approach in summarizing FDA’s guidance on manufacturer MDR reporting requirements, written procedures, recordkeeping, a variety of specific issues and situations, FAQs regarding completion of the MDR report, and common errors that manufacturers make in completing the MDR forms. The end of the document also contains a summary of basic requirements for user facilities, importers and distributors.
The guidance provides helpful information on a wide variety of MDR reporting issues, however summarized below are key clarifications of note in this guidance that appear to reflect new or revised recommendations compared to pre-existing guidance:
a) US manufacturers of devices that are not cleared/approved in the US but are exported to foreign locations, are also subject to the MDR regulation and failure to submit MDR reports is a prohibited act. However, FDA states that they generally do not intend to enforce MDR reporting requirements for devices that are solely exported unless there is a situation identified which necessitates that FDA have information about exported device adverse events. FDA would notify the affected manufacturer(s) in this situation.
b) Once a malfunction has occurred, it is presumed that it will recur. In the past, FDA allowed a “2 year rule” for malfunctions that lead to a death or serious injury. In other words, if a malfunction did not lead to another death or serious injury for a 2 year period,
the malfunction (if it recurred) would not be reportable. The 2-year rule is no longer in effect in the new guidance. Instead, manufacturers should document that a malfunction has not caused or contributed to any additional deaths or serious injuries, and submit a request for and receive an exemption from reporting from FDA in order to not report further malfunctions of this type.
c) Contract manufacturers are also subject to MDR reporting, so that the contract manufacturer and manufacturer that initiated the specifications and distributed the device are both required to report. If desired, the two companies can identify which party they wish to be responsible for MDR reporting (if not both), and should submit a joint (i.e., request from both) exemption request for FDA notifying who will report.
d) A company that initiates a remedial action in response to an adverse event that FDA could consider a Class I recall must submit an MDR report for the event within 5 work days of the decision to initiate the remedial action. If the firm has already filed an initial MDR but later decides to take remedial action, they must file a supplemental MDR notifying FDA of the remedial action to be taken.
e) MDR investigations should involve a “good faith effort” to obtain information and should not focus solely on the number of attempts to obtain such information. A good faith effort should include at least one written request for information (e.g., to the hospital, physician, etc.).
f) Foreign manufacturers are subject to MDR reporting. Importers must submit deaths and serious injuries to FDA and malfunctions to the manufacturer. If a foreign manufacturer and importer decide they want the importer to file reports for which they
both have an MDR reporting obligation, the foreign manufacturer must submit a request to FDA for an exemption.
g) An event should not be considered MDR reportable solely based on an event delaying surgery, however if failure of a device causes a delay in surgery and this delay may have caused or contributed to a death or serious injury to the patient, it would be reportable. The event could still be reportable, however, even if the device did not cause or contribute to a death or serious injury, if recurrence of the event would be likely to contribute to a death or serious injury.
h) Implanted devices that have reached or are near the end of their established life expectancy and are subsequently replaced without a device-related death or serious injury associated with the replacement, are not reportable events, even if surgery is involved.
i) If a patient experience adverse events on different days with the same device, and the events are reportable, each occurrence should be reported as a separate MDR submission.
j) During an inspection, companies must provide FDA full access to hard as well as electronic files.
k)Companies must continue making MDR reports as long as they are in business, even if they have ceased manufacturing the device in question. However, if ownership of the PMA or 510(k) is transferred to another company and the new company explicitly agrees to be responsible for MDR reporting, the first company is no longer required to report. However, the original company should request an exemption from FDA to end its MDR reporting obligations for the devices it manufactured.
Please refer to pages 38-41 of the guidance for a list of the 12 most common errors FDA finds in MDR reports.