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News: FDA to release reports on ASCA pilot in 2019

The US Food and Drug Administration (FDA) has recently released a report that details its work on establishing its Accreditation Scheme for Conformity Assessment (ASCA) pilot in 2019. The reports for this much-anticipated scheme came in a few months after the draft guidance was outlined detailing the standards of the pilot.

The FDA has considered the pilot as one of the latest reauthorizations of Medical Device User Fee Amendments (MDUFA IV) to create an accrediting third-party testing lab scheme with eligible consensus standards for device makers that they can rely on for premarket submissions.