Industry asks FDA to clarify voluntary malfunction reporting program requirements

Medical device industry groups are asking the US Food and Drug Administration (FDA) to provide more clarity on what products will qualify for its Voluntary Malfunction Summary Reporting (VMSR) program, as well as the requirements to qualify for the program.
 
FDA first piloted the VMSR program in 2015 to allow class I and II medical device manufacturers to report malfunctions to the agency on a quarterly basis to reduce administrative burdens on itself and industry. Three years later, after negotiations with the medical device industry during the Medical Device User Fee Amendments (MDUFA IV) deal, the agency formally launched the VMSR program.
 
Toward the end of 2022, regulators published a draft guidance to shed light on what manufacturers need to do to qualify their products for the program. (RELATED: FDA aims to clarify device malfunction summary reporting requirements, Regulatory Focus 8 December 2022)
 
Two major medtech lobby groups, the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA), are asking FDA to update the guidance to further clarify how companies can qualify their devices for the program.
 
In its comments, AdvaMed asked FDA to publish a list of inclusion/exclusion criteria based on the relevant product code types that qualify for the program.
 
“This would help provide direction beyond types of excluded events (e.g., ‘infection’) and clearly delineate what is included or eligibility based on the same procode, problem code, and cause code,” said AdvaMed. “We note company participants have already invested or will be investing significant IT infrastructure and system design to accommodate the VMSR Program and thus clear and consistent eligibility criteria will encourage understanding and increased utility of the program.”
 
“While eligible procodes can be found in the Product Classification Database, it would also be helpful in furtherance of FDA efforts to help manufacturers better understand and use the program to provide a list of codes eligible for VMSR reporting directly on the FDA website,” the group added. “This eligible code list could be updated as needed and serve as a ready complement to the guidance.”
 
Similarly, MDMA argued that the draft guidance does not provide enough information for manufacturers who want to participate in the program to understand the agency’s requirements. The group said FDA should publish additional guidance detailing essential requirements on how to participate and to ensure consistent application of the requirements.
 
“MDMA further encourages FDA to work with major Complaint Handling Software companies to facilitate the development of information technology (IT) solutions capable of supporting VMSR,” the group added.
 
MDMA raised other issues in its comment, including how malfunction summary reports are submitted. The group said that the draft guidance requires malfunction summary reports to be submitted for each unique combination of device brand name, device model and medical device problem code, which could lead to the submission of multiple reports for a specific device. It said that it would be more efficient if manufacturers were allowed to send reports for each unique device brand name or model only and not to require separate submissions for each unique combination of brand name, model and product problem experienced.
 
“Under this approach, manufacturers would still provide all of the problem codes reported for that device or model and ensure that the required details regarding device performance are submitted,” said MDMA. “However, this approach would be more streamlined and reduced the burden on both FDA and manufacturers.”
 
“Similarly, FDA could establish a new medical device report (MDR) form allowing for multiple brand names, devices, models, and problem codes to be included in one document where all the necessary data could be attached in an excel file with standardized columns,” the group added. “A new MDR data entry form designed specifically for summary reports would assist in providing improved functionality and usability of summary reporting as well as subsequent data analytics.”
 
AdvaMed also asked FDA to integrate the use of spreadsheet documents, such as those produced with Excel, so they can be used to submit summary reports. The group said it would make the process more efficient and allow manufacturers to submit a single report rather than a separate report for each grouping.
 
“This would also allow end users to efficiently review and analyze the data,” AdvaMed wrote. “We believe these recommendations are consistent with the goals of the VMSR Program and could be integrated or cross-referenced in the guidance.”
 
The draft guidance specifies that when manufacturers learn that an event in a previously submitted malfunction summary report could be a reportable serious injury or death, they should submit both an individual MDR within 30 calendar days for serious injury or death, and a supplemental summary report to update the initial malfunction summary report. MDMA, said that requirement is too burdensome for manufacturers and suggests that they instead should be allowed to supplement the malfunction summary report.
 
“We recommend that when an event has previously been submitted in a malfunction summary report then requires an individual MDR, the 30 calendar day timeframe should apply to the MDR but manufacturers should not be required to submit the malfunction summary report simultaneously,” said MDMA. “Rather, we believe manufacturers should be allowed to supplement the malfunction summary report consistent with the existing Summary Malfunction Reporting Schedule.”
 
“This approach would reduce burdens on manufacturers while ensuring that the agency promptly receives notice of these events, as FDA would nonetheless be notified of the event within 30 calendar days through the individual report,” the group added. “Permitting manufacturers to submit supplements on the quarterly schedule would allow manufacturers to report supplementary information consistent with their current obligations and avoid the need for manufacturers to update event numbers outside of the established cadence for such reporting.”