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FDA IVD de-regulation efforts may require statutory changes -- Alpert.

This article was originally published in The Gray Sheet

Executive Summary

IN VITRO DIAGNOSTICS DE-REGULATION MAY REQUIRE "STATUTORY CHANGES," FDA Office of Device Evaluation Director Susan Alpert said Nov. 6 at an Arlington, Virginia, conference on IVD regulation, sponsored by the Health Industry Manufacturers Association. To be more "efficient and effective" in regulating IVDs, Alpert said, "we're trying from the inside to look at what regulatory changes we can make, but there may in fact also be statutory changes that are necessary."

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