FDA CLASS I 510(K) EXEMPTION REG COVERS 189 DEVICES, KEEPS 53 SUBJECT TO REVIEW; REFORM LAW EXEMPTIONS TO ELIMINATE 600-700 SUBMISSIONS ANNUALLY
This article was originally published in The Gray Sheet
FDA's recent exemption of 62 Class II devices combined with a reg to exempt 189 Class I devices slated for publication Feb. 2 are expected to eliminate 600 to 700 510(k) submissions annually, staffers say.
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