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S. 2977

BillFederalSenateIn Committee
MEDTECH Act
About This Bill
Committee
Latest Action · December 4, 2014
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced
December 4, 2014
Cosponsors (1)
0D 1R
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Summary

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Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act - Amends the Federal Food, Drug, and Cosmetic Act to exclude from regulation as a medical device: administrative, operational, or financial records software used in health care settings; products intended for health maintenance outside of medical treatment; electronic patient records, excluding diagnostic image data, provided that related software is validated prior to marketing, consistent with the standards for devices; software for clinical laboratory test reports; and software that provides medical recommendations and the basis for those recommendations to health care professionals, with exceptions for products related to regulated devices.

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