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...Review: HHS Finalizes Rule Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; Senate...
JD Supra· 21 minutes agoThis...week, HHS finalized a rule that strengthens protections against disability discrimination in programs that receive HHS funding, FDA finalized a rule regulating LDTs ...
FDA Releases Final Rule on Regulation of Laboratory-Developed Tests
GenomeWeb News· 7 days agoThe rule makes explicit that LDTs are in vitro diagnostics and as such are subject to oversight by...
FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In...
JD Supra· 4 days agoOn April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory ...
FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests | JD Supra
JD Supra· 4 days agoThe final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including ...
FDA Issues Final Rule Regulating Many Laboratory-Developed Tests as Medical Devices | JD Supra
JD Supra· 5 days agoThe final rule amends FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FDCA), ...
JD Supra: Non-Lab Diagnostics: FDA Regulatory Considerations
JD Supra· 21 hours agoCompanies considering entering the over-the-counter (OTC) diagnostic test space should fully understand their regulatory obligations.
JD Supra: Your Digital Health Regulation Questions Answered
JD Supra· 19 hours agoWondering how the FDA will regulate your digital health or software product? A new navigator tool can help determine the FDA’s potential oversight. The ...
Cassidy bashes new FDA testing rule
Axios· 7 days agoSenate HELP Committee Ranking Member Bill Cassidy is taking the FDA to task for its new rule increasing oversight of laboratory-developed tests. Why it...
FDA issues final rule regulating LDTs as medical devices
Medical Device Network via Yahoo Finance· 6 days agoThe FDA ruling follows years of industry back and forth and sees the government body choosing to...
FDA Announces Final Regulation Governing Laboratory Developed Tests | JD Supra
JD Supra· 5 days agoThe U.S. Food and Drug Administration (FDA or Agency) announced on April 29, 2024, in a forthcoming and long-awaited final rule that laboratory developed tests (LDTs) will ...