FDA issues final rule on adverse event reporting for manufacturers

Editor's Note

The Food and Drug Administration (FDA) on November 8 published its final rule on the requirements for reporting adverse events by medical device companies, the November 14 Medical Design & Outsourcing reports.

The final rule walks back much of the burden for contract manufacturers that was in the draft rule and clarifies the reporting of user error.

The FDA last week issued final guidance for medical device companies on the requirements for reporting adverse events that walked back much of the burden for contract manufacturers.