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Key Takeaways from FDA’s Final Rule on Laboratory-Developed Tests | JD Supra
JD Supra· 1 day agoThe US Food and Drug Administration (FDA) on April 29, 2024 announced its Final Rule on laboratory-developed tests (LDTs). This marks the beginning of the end of ...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
JD Supra· 1 day agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency ...
FDA under fire: Pared-down LDT Final Rule leaves unanswered questions | JD Supra
JD Supra· 1 day agoFDA has finalized its landmark proposed rule that will amend the definition of “in vitro diagnostic (IVD) products” in 21 CFR § 809.3 to make explicit that IVDs are medical ...
FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests | JD Supra
JD Supra· 6 days agoThe final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer ...
Social media influencers are praising raw milk. Here's why it's dangerous for humans
The Florida Times-Union via Yahoo News· 23 hours agoFood and Drug Administration (FDA) said in a news release. "We are also committed to continued...
The End of an Era? FDA Finalizes LDT Rule But Grandfathers Many Existing LDTs | JD Supra
JD Supra· 1 day agoOn May 6, 2024, the Food and Drug Administration (FDA) published its final rule for laboratory developed tests (LDTs). The final rule cemented the agency’s forecasted decision ...
JD Supra: Non-Lab Diagnostics: FDA Regulatory Considerations
JD Supra· 3 days agoCompanies considering entering the over-the-counter (OTC) diagnostic test space should fully understand their regulatory obligations.
FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests | JD Supra
JD Supra· 2 days agoThe Food and Drug Administration (FDA) published its long-awaited Final Rule that will regulate laboratory developed tests (LDTs) as in vitro diagnostic (IVD) medical devices ...
FDA Issues Final Rule on Laboratory-Developed Tests | JD Supra
JD Supra· 6 days agoOn April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro...
...Review: HHS Finalizes Rule Prohibiting Disability Discrimination; FDA Finalizes LDT Rule; Senate...
JD Supra· 2 days agoThis...week, HHS finalized a rule that strengthens protections against disability discrimination in programs that receive HHS funding, FDA finalized a rule regulating LDTs ...