02 August 2018-Bucharest, Romania. People waiting and watching in the public park Herastrau for the movie to start on the projection screen of the open air cinema

FDA Finalizes Rule Regulating Laboratory Developed Tests

Start
FDA’s Final Rule regulating Laboratory-Developed Tests (LDTs) has been published in the Federal Register yesterday, May 6, 2024. This follows a decades-long effort by some stakeholders to clarify the regulatory status of these tests. This landmark rule was finalized with lightning speed, with the Proposed Rule published in the Federal Register on October 2, 2023….
By: Polsinelli
Previous Story

NIST Releases New Draft Guidance to Improve Safety, Security and Trustworthiness of AI Systems

Next Story

FDA Finalizes Rule to Phase Out Enforcement Discretion of Laboratory-Developed Tests