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Recently Published Guidance from the FDA

There have been a number of draft and final guidance documents published by the US Food and Drug Administration (FDA) in the past several weeks. Here are several relevant to clinical research. Draft Guidance Documents: Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria Guidance for Industry https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm604195.pdf In this draft guidance, the FD