In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction summary reports for certain medical devices on a quarterly basis.
The agency first piloted a program to allow class I and II medical device manufacturers to report malfunctions to the agency on a quarterly basis in 2015. Following the Medical Device User Fee Amendments (MDUFA IV) negotiations, FDA formalized the Voluntary Malfunction Summary Reporting (VMSR) program in 2018.
FDA explains in the guidance that it receives more than two million medical device reports (MDRs) annually that detail suspected device-related deaths, serious injuries and malfunctions, with malfunctions making up the majority of such reports. Allowing sponsors to aggregate voluntary reports and submit them on a quarterly basis instead of on a rolling basis may be more efficient and useful to all stakeholders, according to FDA…
