Senators Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) on Monday reintroduced a bill to exempt low-risk medical software and mobile apps from regulation by the U.S. Food and Drug Administration in an attempt to provide greater certainty regarding what software will be regulated by the agency to protect consumers.
The bipartisan Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act seeks to amend the Federal Food, Drug, and Cosmetic Act to limit and clarify the FDAs role regarding the regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and decision support software.
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