On July 9, 2013, the FDA issued a draft guidance document titled “Medical Device Reporting for Manufacturers.” Written in a question and answer format, the draft guidance provides the FDA’s current views on the FDA’s medical device reporting (MDR) regulation, 21 C.F.R. part 803. This document updates the FDA’s policy and further clarifies the FDA’s interpretations of the [MDR] regulation requirements. It will supersede “Medical Device Reporting for Manufacturers,” dated March 1997, once it has been finalized.
Comparison Between the Draft Guidance and the 1997 Guidance
The FDA leaves much of the advice from the 1997 guidance intact (see the article “FDA Accused of Expanding Reporting Requirements”). However, two differences between the 1997 guidance and the draft guidance are notable:
- The FDA has eliminated the “two-year rule”(i.e., the two-year time period for removing the presumption that a malfunction will cause or contribute to a serious injury or death).
- The FDA did not update the 1997 guidance to eliminate references to the baseline reports.
Key Aspects of the Draft Guidance
After focusing on the purpose of the draft guidance and the MDR regulation (section one of the draft guidance), the FDA reiterates and expands upon key statements from the 1997 guidance regarding manufacturers’ MDR responsibilities for reporting adverse events to the FDA. The FDA also adds new recommendations (see “FDA Issues Draft Guidance on Medical Device Reporting for Manufacturers” for more information on these recommendations). Most key aspects of the draft guidance concern:
1. Manufacturer reporting requirements (section two of the draft guidance):
- The FDA confirms that until the FDA issues a rule to establish malfunction reporting requirements for such devices, manufacturers of all these products must provide malfunction MDRs as required in 21 C.F.R. (section 2.1).
- The FDA reinforces the fact that user error may be reportable as an MDR if the incorrect use of the device causes or contributes to a death or serious injury (section 2.6).
- The FDA reiterates the types of malfunctions that the agency considers reportable as MDRs and thus interprets the word “likely” in the requirement to report as MDRs malfunctions that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, and gives examples of reportable malfunctions(section 2.14).
- The FDA clarifies that even if a malfunction can be corrected during service or maintenance, the malfunction is nevertheless reportable if it would be likely to cause or contribute to a death or serious injury (section 2.14).
- The FDA provides for the first time an explanation of devices it considers similar for purposes of reporting malfunctions (i.e., malfunctions are reportable if the device or a similar device marketed by the manufacturer would be likely to cause or contribute to death or serious injury if the malfunction were to recur) (section 2.14).
- The FDA provides more detail about the agency’s expectations for manufacturers’ efforts to obtain additional information about reported events (section 2.23).
- The FDA provides details about requesting MDR reporting exemptions (section 2.27).
2. Specific issues and situations (section four of the draft guidance):
- The FDA addresses the common practice in which manufacturers submit an MDR for any situation that causes a delay in surgery. If no death or serious injury occurs, delays in surgery may still be reportable if the device malfunctioned and the malfunction (and the associated delay) would be likely to cause or contribute to a death or serious injury if the malfunction were to recur (section 4.1.1).
- The FDA provides new information about how to calculate the expected life of the device, as relevant to the requirement in 21 C.F.R. § 803.18(c) that manufacturers keep MDR files for two years or the expected life of the device, whichever is longer (section 4.2).
- The FDA explains that even if an adverse event was disclosed as a potential risk or complication in the device labeling, the event is nevertheless reportable as an MDR if the device caused or contributed to a death or serious injury (section 4.3.1).
- The FDA provides further information on the good faith effort that the FDA expects manufacturers to undertake and also explains that when a company does not receive a device back from the reporting facility or individual, the manufacturer must still analyze the reported event (section 4.9.1).
- The FDA addresses the often confusing situations involving alarms that, if acted upon, may preclude serious injury or death of a patient (section 4.13.1).
- The FDA provides detailed information about its expectations for obtaining additional information about MDR reportable events contained in scientific articles and other literature (section 4.16.2).
3. Completion of the MDR report (section five of the draft guidance):
- The FDA identifies in particular the 12 commonly observed problems in MDR reports (Form 3500As). Examples include providing duplicated report sequence numbers the Manufacturer Report Number box and Block G-9, and including multiple devices or events in the same report (section 5.12) (see “FDA Issues Extensive Guidance Document Covering Medical Device Reporting Procedures” for more information on this point).
Manufacturers should review the entire draft guidance and should consider complying with or commenting on its recommendations prior to its finalization.
The FDA is accepting comments on the draft guidance until October 7, 2013 (docket number FDA-2013-D-0743).
This entry was written by guest blogger Isabelle Chivoret, a student at the Paris Bar School. Isabelle holds a Ph.D. in private law, in the field of pharmaceutical law.