FDA has posted the final version of a draft guidance on the agency's refuse-to-accept (RTA) policy for 510(k) applications, which deals with at least one issue raised by industry in connection with the draft. The final guidance notes that a checklist to be used by reviewers will still include whether the application addresses product labeling, although the agency advises that the term "addressed" does not mean that the adequacy of that labeling will be reviewed during the checklist review, only that FDA staff will evaluate the filing to ensure it "includes information pertinent to" the related requirements. Read More
