FDA issues draft guidance for staff on premarket 510(k) process

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The FDA has issued draft guidance to clarify current review practices of premarket notification 510(k) submissions for FDA staff and manufacturers of medical devices.

The guidance identifies and explains various decision points the FDA uses to determine substantial equivalence. As draft guidance, the document is not binding but is distributed for comments and suggestions by 120 days after its publication in the Federal Register.

Publishing the draft Dec. 28, the agency noted that the guidance is “not intended to implement significant policy changes to the current 510(k) review process. Rather, the intent of this guidance is to enhance the predictability, consistency and transparency of the 510(k) program by describing in greater detail the regulatory framework, policies and practices underlying the FDA’s 510(k) review."

This guidance also updates the FDA’s policies with respect to the Special 510(k) program.

The FDA pointed out that guidance documents do not establish legally enforceable responsibilities but, rather, describe the agency’s current thinking on a topic. As such, they “should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” said the FDA.

Click here to read the draft guidance and for information on submitting comments and suggestions.