The FDA’s traditional medical device reporting (MDR) program has served to aid the agency’s efforts to track device malfunctions implicated in adverse events, but the MDR system is not the most efficient way to handle some of the lower-risk malfunctions. The FDA has released a draft guidance for an alternative — the voluntary malfunction summary reporting (VMSR) program — which eases the burden of post-market surveillance for a large number of device types.
The VMSR was introduced in 2018 to begin the process of replacing a similar program that was phased out the following year — the alternative summary reporting (ASR) program. The ASR program, which ran from 1997 to June 2019, was established to collect data on well-known and well-understood events associated with specific categories of devices. The data from ASR reports were not available in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database until 2017, when the FDA began requiring manufacturers to file companion MDRs for their ASR filings. Prior to 2017, data from ASR reports were completely invisible to the public.
High-Risk Devices Are Not Necessarily Good Candidates for VMSR
The FDA stated that it receives more than 2 million MDRs each year, with device malfunctions making up the majority of those reports. The VMSR program allows manufacturers and developers of software as a medical device (SaMD) to file quarterly voluntary reports for certain malfunctions that are related to devices with specific product codes. Participation in the program is voluntary, but several categories of device types are generally not eligible unless the FDA grants an exemption from standard MDR reporting. Class III, high-risk devices and class II devices that are permanently implantable, or are intended for use to support or sustain human life, are less likely than most class II devices to be admitted into the program. Reusable devices that do not readily lend themselves to reprocessing are also unlikely to be made eligible, according to the draft guidance.
As a reminder, MDR requirements as set out in Part 803 include that the manufacturer/developer submit a report for an adverse event when becoming aware of information that suggests that a malfunction would be likely to cause or contribute to a serious death or injury were the malfunction to occur again. This holds true regardless of the source of the information, and while MDRs are typically due in 30 days, a 5-day deadline applies if remedial action is required to prevent an unreasonable risk of substantial harm to public health.
In the past, there has been disagreement between manufacturers and the FDA as to when the manufacturer knew or should have known about a device malfunction or an adverse event, but physicians and hospitals have not always proven themselves fully reliable in filing these reports. In 2016, the FDA conducted inspections of hospital data systems regarding adverse events, but the agency’s webpage for that information is no longer available. As was implied in a February 2017 journal article, manufacturers cannot take for granted that hospitals are forwarding any and all malfunction and adverse event data to the FDA, leaving manufacturers in a difficult position at times with regard to the notorious “knew or should have known” problem.
The draft guidance states that the VMSR program operates under a set of six general principles, including that:
- The report provides the FDA with sufficient information to understand the malfunction;
- The manufacturer communicates information about an imminent hazard as quickly as possible;
- Summary malfunction reporting is filed in a common format for the reporting system used;
- The manufacturer is transparent in the information that is reported, although the FDA will redact any information that is protected from disclosure under applicable disclosure laws.
Summary reporting should not be duplicative of information received by the FDA through other processes, and the FDA emphasized in the draft guidance that any information sent through the VMSR program must also be retained in the manufacturer’s MDR files. Participation in the program also does not relieve the manufacturer of its responsibility for complaint handling requirements under Part 820.198.
Form 3500A May Not be Ideal for VMSR
There is no need to notify the FDA of participation since a manufacturer or developer may self-elect to take part, but there are elements of the draft that were not looked upon favorably by trade associations. The section of the draft that describes the use of form 3500A in the VMSR program states that a separate summary malfunction report should be submitted for each unique combination of brand name, device model, and MDR adverse event code. One of the industry representatives that commented on the draft advised that this approach would require separate reports for each individual problem and for each combination of problems with a device.
One possible solution would be to create a new form to replace form 3500A, which would be formatted to allow the manufacturer to provide device malfunction reporting for multiple brand names, devices, models, and problem codes. This would be accompanied by a standardized spreadsheet that would provide the data in a format that could be easily accessed by analytical software. A similar set of observations was offered by the other source of commentary on the draft.
The FDA’s product classification database includes a function that sorts records for eligibility for summary malfunction reporting, which lists 1,000 device types that are eligible for the VMSR program. The list ranges from class II radioimmunoassays for angiotensin and renin (product code CIB) to class III devices such as mechanical heart valves (product code LWQ). We would highlight that this program offers a way to streamline data collection while providing deeper insight into device malfunction trends, and thus is an opportunity that should be given significant consideration.