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Toward the end of 2022, regulators published a draft guidance to shed light on what manufacturers need to do to qualify their products for the program.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)…
