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FDAMA 510(k) Exemption Provision Utilized By Abbott, Few Others

This article was originally published in The Gray Sheet

Executive Summary

FDA approval of Abbott Laboratories' petition for 510(k) exemption for the firm's hypothyroidism total triiodothyronine (T3) test system would be the second for an Abbott T3 assay, albeit for a different indication.

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Triiodothyronine tests

Oct. 18 FDA final rule exempts from premarket 510(k) notification requirements triiodothyronine (T3) test systems indicated for measuring the hormone T3 in serum and plasma. The rule grants a petition request from Abbott (1"The Gray Sheet" July 24, 2000, p. 11)

Triiodothyronine tests

Oct. 18 FDA final rule exempts from premarket 510(k) notification requirements triiodothyronine (T3) test systems indicated for measuring the hormone T3 in serum and plasma. The rule grants a petition request from Abbott (1"The Gray Sheet" July 24, 2000, p. 11)

Four 510(k) Exemption Petitions For Class II Devices Rejected By FDA

FDA has denied the first four petitions submitted by manufacturers requesting exemptions for Class II devices from 510(k) requirements under provisions of the FDA Modernization Act.

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