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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Policy & Legislation
FDA Law Blog | Jan 20, 2016

Proposed Changes to FDA 501(k) RTA Policy Seen as Positive

CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance). This change was done with so little fanfare that many did not even notice .The changes made to the 510(k) RTA policy appear to try to curb some of these mindless RTA comments by giving “FDA staff . . . discretion to determine whether missing checklist items are needed to ensure that the submission is administratively complete to allow the submission to be accepted.” New RTA Guidance at 7. Reviewers are also now permitted to “request missing checklist items interactively from submitters during the RTA review.”

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