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To RRA, Or Not To RRA? BD Talks Decision-Making Around FDA Requests For Remote Regulatory Assessments

 
• By Shawn M. Schmitt

Three Becton Dickinson facilities have been approached by the US agency to take part in the voluntary virtual assessments; the medtech giant declined one and accepted two. BD’s VP of quality and regulatory compliance explains why.

Rear view of a businessman in front of a crossroad, fork junction where a road is split in two different ways.

To RRA, or not to RRA? That’s the question facing many medical device manufacturers that are being approached by the US Food and Drug Administration to participate in a virtual quality systems assessment in lieu of an on-site facility inspection.

The FDA established the voluntary Remote Regulatory Assessment (RRA) program earlier this year to help it ascertain a device maker’s...

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