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Class I IVD 510(k) Exemptions Should Not Have Limitations - HIMA

This article was originally published in The Gray Sheet

Executive Summary

FDA should modify its Feb. 2 list of Class I 510(k)-exempt devices either by removing the limitations on in vitro diagnostic products or articulating the rationale for treating IVDs differently from other devices, the Health Industry Manufacturers Association says in May 4 comments to the agency.

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