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FDA reclassification proposed rule

This article was originally published in The Gray Sheet

Executive Summary

Agency is extending comment period for three of 38 pre-1976 devices proposed for reclassification from Class III to Class II. Comments must be submitted 90 days from Nov. 22. Specifically, the action relates to in-dwelling blood carbon dioxide partial pressure analyzers, blood hydrogen ion concentration analyzers, and blood oxygen partial pressure analyzers. Original mass reclassification was published in March 15, 1999 issue of Federal Register (1"The Gray Sheet" March 22, 1999, p. 10). Guidance for premarket 510(k) notification submissions for indwelling blood gas analyzers is released in the Nov. 22 Federal Register. Comments are due by Feb. 20
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