This article was originally published in The Gray Sheet
FDA guidance issued Aug. 2 recognizes five standards for use in abbreviated 510(k) applications. Cardiovascular brachytherapy devices for prevention of restenosis are not addressed by the document. While the guidance is appropriate for sponsors seeking general claims for photon-emitting brachytherapy sources, specific claims should be handled using the agency's "Guidance for Industry on General/Specific Intended Use"
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