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FDA’s 5 Steps To A Successful ASCA Pilot Submission

Agency holds webinar on consensus standard program, announces participating labs

 
• By Elizabeth Orr

Sponsors participating in the US FDA’s Accreditation Scheme for Conformity Assessment pilot program should work closely with the lab and be prepared for a few extra steps in putting a submission together, agency staff say.

Five hand-drawn lightbulbs on a whiteboard.
• Source: Shutterstock

Participants in the US Food and Drug Administration’s Accreditation Scheme for Conformity Assessment (ASCA) pilot program should follow five steps to develop program-ready submissions, agency staff said at a 13 April webinar.

The pilot, launched last September, allows manufacturers to outsource some product testing to accredited labs that can certify that devices meet international standards. It’s intended to help streamline and globally...

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