The Food and Drug Omnibus Reform Act of 2022

Legislation enacted in December 2022 to fund the federal government through September 2023 included a wide range of new statutory provisions important to medical product companies regulated 
by the FDA.

The Food and Drug Omnibus Reform Act of 2022 (FDORA), included in the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328 (Dec. 29, 2022), gives the agency targeted new enforcement authorities, advances diversity in clinical trials, addresses artificial intelligence and machine learning in medical devices, seeks to bolster device cybersecurity, and codifies FDA policies allowing the communication of truthful and non-misleading information about investigational drugs and devices to payors, formulary committees and similar entities. Other FDORA provisions respond to recent judicial decisions that addressed the scope of the agency’s regulatory powers.

This analysis from the experts at Thompson FDA unpacks the critical changes enacted under FDORA in the areas of FDA enforcement, clinical trial regulation, medical device regulation, and the regulation of medical product advertising and promotion. Thompson FDA will continue to provide essential updates on these developments as the FDA implements FDORA through new agency guidance, policies and enforcement actions.

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