FDA Attempted to Ease Reporting Timeframes for Medical Device Reporting Requirements–Did it Succeed?


The US agency launched a voluntary summary reporting program last year to streamline reports for qualifying product malfunctions. It’s a positive step forward for FDA, 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 last year, it intended to promote efficiency in the medical device malfunction reporting process, while ensuring enough information is gathered to effectively monitor devices.

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