Voluntary Malfunction Summary Reporting One Year Out

Mir Ali, Paula Burge, and Alexander Garnick, MedTech Strategist

When the US Food and Drug Administration finalized its Voluntary Malfunction Summary Reporting Program last year, it intended to promote efficiency in the medical device malfunction reporting process, while ensuring enough information is gathered to effectively monitor devices. 

As its one-year anniversary approaches in September, the voluntary program, which was developed based on results of a two-year pilot, is gaining traction. Additionally, FDA recently announced that it has ended the Alternative Summary Reporting program for all medical devices, emphasizing the use of the VMSR program instead. 

But the newer program might only provide limited benefits to participating manufacturers, as it forces them to accommodate various methods of reporting. Manufacturers debating whether to join the program must weigh the pros and cons, and, in either case, set themselves up for reporting success.

The voluntary summary program was created as an alternative method of complying with the Medical Device Reporting (MDR) requirements in section 519 of the Federal Food, Drug, and Cosmetic Act (21 USC § 360i) and the regulations in 21 CFR Part 803. Only manufacturers qualify for the program, not importers or user facilities. 

Under the program, manufacturers of eligible Class I and Class II medical devices can elect to voluntarily submit malfunction reports in a summary format quarterly, rather than utilizing the electronic format of form FDA 3500A as is currently required for reporting upon becoming aware of a malfunction occurring. More than 5,600 device types are eligible, and FDA makes the reports publicly available in MAUDE, its online database of reported adverse events.  

It’s a positive step forward for FDA, but companies should weigh the pros and cons before deciding to participate, say Mir Ali, Paula Burge, and Alexander Garnick from Guidehouse.

Managing Consultant

Senior Consultant

Senior Consultant

Download: Voluntary Malfunction Summary Reporting One Year Out
Back to top