I come not to praise the effort to repeal the device tax, or even to criticize it. I’m just here to give it a proper burial because it has been one heck of an effort. Industry continues to assert it will do everything it can to peel this tax monkey off its back, but there are a number of reasons I believe it’s just not going to happen. But that doesn’t mean all is lost. The first reason I see the device tax repeal as a goner is...

FDA has posted the final version of a draft guidance on the agency's refuse-to-accept (RTA) policy for 510(k) applications, which deals with at least one issue raised by industry in connection with the draft.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.