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Ready, Set, Guidance: FDA Releases Final Details Ahead Of ASCA Pilot Launch

 
• By Elizabeth Orr

A trio of newly finalized guidance documents from the US agency dated 25 September explain how the Accreditation Scheme for Conformity Assessment pilot will work, and what biocompatibility and safety standards will apply.

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A trio of final guidance documents from the US Food and Drug Administration dated 25 September detail the approach and standards the agency will apply during its Accreditation Scheme for Conformity Assessment (ASCA) pilot program, which is officially launching on 25 September.

ASCA, which will allow manufacturers to outsource some product testing to accredited labs that can certify that devices meet international...

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