Regulatory Focus™ > News Articles > FDA Calls for Comments on Adverse Event Reporting for Medical Devices

FDA Calls for Comments on Adverse Event Reporting for Medical Devices

Posted 15 February 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is calling for medical device manufacturers, importers and facility owners to provide feedback on how FDA collects information related to reports of serious adverse events-or potential events-related to medical devices.

The collection of this information is currently mandated under §519(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act), which says that "whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (A) May have caused or contributed to a death or serious injury, or (B) has malfunctioned and that such device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur."

Medical device facilities are also obligated to report information to FDA within 10 days of being made aware of a medical device used in the facility that has contributed to the death or serious injury of a patient.

"Complete, accurate, and timely adverse event information is necessary for the identification of emerging device problems," writes FDA. "Thus FDA is requesting approval for these information collection requirements which are being implemented under part 803 (21 CFR part 803)."

Comments should pertain to the necessity of the information collected, the burdens of collection, ways to improve the collection of information and ways to automate the collection process.

Comments on the proposal are due by 16 April 2012.


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