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

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 general compliance with agency rules and expectations. RRAs are not...