ARTICLE SUMMARY:
The US FDA launched a voluntary summary reporting program last year to streamline reports for qualifying product malfunctions. It’s a positive step forward for the agency, but companies should weigh the pros and cons before deciding to participate. By Mir Ali, Paula Burge, and Alexander Garnick, Navigant.
When the US Food and Drug Administration finalized its Voluntary Malfunction Summary Reporting Program (VMSR) last year, it intended to promote efficiency in the medical device malfunction reporting process, while ensuring it gathers enough information effectively monitor devices.
