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US FDA Seeks Input On Standing Up Conformity Assessment Pilot

 
• By Elizabeth Orr

In the latest user-fee agreement, FDA and industry agreed to pilot a conformity assessment program where third-party accredited test labs could affirm a manufacturer's conformance to consensus standards, potentially expediting pre-market reviews.

US FDA wants stakeholder input on a pilot program that could speed some device approvals by allowing third-party labs to determine whether products meet consensus standards, a May 16 Federal Register notice states.

The concept behind the Accreditation Scheme for Conformity Assessment (ASCA) pilot program was developed during the most recent device user...

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