The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
The “Content of Human Factors Information in Device Marketing Submissions” draft guidance offers a risk-based framework to guide manufacturers on the human factors information that should be included in a marketing submission to the FDA. It also provides the agency’s current thinking on this topic based on stakeholder feedback regarding the draft guidance “List of Highest Priority Devices for Human Factors Review” and is intended to be used to complement the FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices” when finalized.
“Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers” proposes recommendations to help manufacturers understand and use the VMSR program, which was developed to reduce the number of individually reported device malfunction medical device reports (MDRs) that manufacturers must submit and allows the FDA to get a more efficient understanding of certain malfunction issues via a summary report. The new draft guidance is intended to further explain, but not change, the conditions of the VMSR program, said the FDA.
For eligible device types, the VMSR allows manufacturers to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis. Reports from this voluntary program are publicly available in the MAUDE database. Reports of a death or serious injury are not allowed to be submitted via the VMSR Program, and the FDA may still require individual malfunction reports—instead of summary reports—for devices that are eligible for the program, such as when individual reports are necessary to address a public health issue.