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From Electronic Docs To FOIA Requests, FDA Lays Bare Its Process For Remote Regulatory Assessments

 
• By Shawn M. Schmitt

A document from the US FDA obtained by Medtech Insight advises medical device manufacturers on how a voluntary Remote Regulatory Assessment will unfold. RRAs are being conducted by the agency in lieu of on-site facility inspections because of the COVID-19 pandemic.

FDA building.

Device makers that agree to a Remote Regulatory Assessment by the US Food and Drug Administration are presented with a three-page explainer of how the agency plans to perform the RRA.

The FDA’s document, sent to a Florida device firm and obtained by Medtech Insight, advises manufacturers on how best to transfer electronic files to the agency and who to...

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