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From Health Law Daily, August 17, 2018

FDA provides alternative for submission of device malfunction reports

By Patricia K. Ruiz, J.D.

Device manufacturers now have an alternative means for reporting certain device malfunctions. Rather than submitting individual device malfunction medical device reports (MDRs), manufacturers may submit a summary form on a quarterly basis. The Voluntary Malfunction Summary Reporting Program (VMSRP) allows the FDA to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments. This streamlined malfunction reporting program reflects goals submitted to Congress (Notice, 83 FR 40973, August 17, 2018).

MDRs. A manufacturer must submit an individual MDR when it becomes aware of information from any source reasonably suggesting that one of its marketed devices malfunctioned and that 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 occurred again (reportable malfunctions). According to the FDA, it receives hundreds of thousands of MDRs reporting suspected device-associated deaths, serious injuries, and malfunctions.

Alternative summary reporting. In December 2017, the FDA issued a notice outlining its proposal to grant an alternative to permit manufacturer reporting of certain device malfunctions in summary form on a quarterly basis (Notice, 82 FR 60922, December 26, 2017). All devices remain subject to MDR reporting requirements to protect public health. However, for many devices, the FDA found it appropriate to permit manufacturers to submit summary reports on a quarterly basis, rather than individual, 30-day malfunction reports. To assist manufacturers and the public in identifying which products are eligible for participation in the VMSRP, the FDA’s Product Classification Database has been updated to reflect eligibility. The FDA provides details on the format of the malfunction reporting summary.

Individual reports required. Because the VMSRP merely provides an alternative submission schedule, if a manufacturer does not submit quarterly reports, it must submit individual malfunction reports. Reportable death or serious injury events are required to be reported to the FDA within the mandatory 30-calendar-day timeframe. Furthermore, a five-day report must be filed if a manufacturer becomes aware of an MDR reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. The FDA lists other situations in which individual reporting is required, including:

  • a reportable malfunction is associated with a five-day report;
  • a reportable malfunction is the subject of certain device recalls;
  • FDA has determined individual MDR reporting to be necessary to address a public health issue; and
  • a new type of reportable malfunction occurs for a device.

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