On August 17, 2018, FDA announced that it finalized its Voluntary Malfunction Summary Reporting Program (“Program”). The Program is intended to reflect the goals for streamlining manufacturer malfunction reporting that FDA and industry agreed to in the Medical Device User Fee Amendments 2017 (MDUFA IV) Commitment Letter. The finalized Program is based on positive findings from a 2015 pilot program and public comments submitted to a 2017 Federal Register proposal.
The Program allows certain manufacturers to report some device malfunction medical device reports (MDRs) in summary form on a quarterly basis. The Program is intended to offer an efficient, streamlined approach to report malfunctions while simultaneously maintaining enough detail for FDA to effectively monitor devices. According to FDA Commissioner Scott Gottlieb, the Program “will allow [FDA] to more efficiently detect potential safety issues and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices.”
In the Federal Register notice announcing the Program, FDA stated that it has determined that for many devices, “it is appropriate to permit manufacturers to submit malfunction summary reports on a quarterly basis, for certain malfunctions, instead of individual, 30-day malfunction reports.” Under 21 C.F.R. § 803.19, FDA has made this voluntary reporting alternative available for devices within eligible product codes. The agency’s searchable Product Classification Database has been updated to reflect eligibility for participation in the Program.
FDA created the initial list of product codes eligible for the Program based on recommendations proposed by industry representatives as well as comments received on the 2017 program proposal. Going forward, devices that fall under product codes in existence for less than two years generally will not be eligible for the Program, unless FDA issues a new code for administrative reasons. FDA will review new product codes after they have been in existence for two years. Manufacturers, however, can submit requests to the agency for a product code to be added to the Program list.
If they prefer, manufacturers of devices in eligible product codes may continue submitting individual, 30-day malfunction reports in compliance with §§ 803.50 and 803.52. To participate in the Program, however, manufacturers do not have to submit an application to FDA. The Program applies only to reportable malfunction events that manufacturers become aware of on or after August 17, 2018, and FDA’s deadline for accepting the first round of quarterly reports for the Program is October 31, 2018. To help prepare for the first deadline, the agency’s Federal Register notice finalizing the Program provides further information, including: (1) the format for summary malfunction reports, (2) the schedule and other logistics for submission of reports, (3) considerations for combination products, and (4) the submission of supplemental reports.
Finally, the Program includes notable limitations and is not available if any of the following conditions exist:
- Death or serious injury events. The Program does not apply to reportable death or serious injury events. A manufacturer must report these events to FDA within the mandatory 30-calendar-day timeframe, under §§ 803.50 and 803.52, or within the 5-work-day timeframe under § 803.53. According to FDA, if a manufacturer participating in the Program becomes aware of any information reasonably suggesting that a device that it markets may have caused or contributed to a death or serious injury, the manufacturer should submit an individual MDR for that event.
- Reportable malfunction associated with a 5-day report. After submitting a 5-day report under § 803.53(a) (i.e., where remedial action is necessary to prevent an unreasonable risk of substantial harm to public health), all subsequent reportable malfunctions of the same nature that involve substantially similar devices must be submitted as individual MDRs in compliance with §§ 803.50 and 803.52, until the date that the remedial action has been terminated to FDA’s satisfaction. Summary reporting of malfunctions may then resume on the regularly scheduled cycle. Likewise, after submitting a 5-day report under § 803.53(b) (i.e., reports submitted in response to a written request from FDA), the manufacturer must submit, without further requests, individual 5-day reports for all subsequent reportable malfunctions of the same nature that involve substantially similar devices for the time period specified in the written request.
- Reportable malfunction is the subject of certain device recalls. When a device is the subject of a recall involving the correction or removal of the device to address a malfunction and that correction or removal is required to be reportable under 21 C.F.R. part 806, all reportable malfunction events of the same nature that involve the same or similar device marketed by the manufacturer must be submitted as individual MDRs in accordance with §§ 803.50 and 803.52, until the date the recall is terminated. After the recall is terminated, summary reporting may resume on the regularly scheduled cycle.
- FDA has determined that individual MDR reporting is necessary to address a public health issue. If FDA determines that individual malfunction events are necessary to provide additional information and more rapid reporting for an identified public health issue involving certain devices, manufacturers must submit reportable malfunction events for those devices as individual MDRs in compliance with §§ 803.50 and 803.52.
- FDA has determined that a manufacturer may not report in summary reporting format. FDA may determine that a specific device manufacturer is no longer allowed to participate in the Program. Reasons include, but are not limited to, failure to comply with applicable MDR requirements under Part 803, failure to follow the conditions of the Program, or the need to monitor a public health issue.
- A new type of reportable malfunction occurs for a device. If a manufacturer becomes aware of information reasonably suggesting a reportable event has occurred for a device that the manufacturer markets and the reportable malfunction is a new type of malfunction that the manufacturer has not previously reported to FDA for that device, the manufacturer must submit an individual report for that reportable malfunction in compliance with §§ 803.50 and 803.52. After submission of the initial individual report, subsequent malfunctions of this type may be submitted in summary form, unless any of the other conditions described above apply.
We continue to monitor this and other MDR developments.