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Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

4/22/2025 / Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Oversight , Regulatory Requirements

How New Executive Orders May Affect FDA’s Medical Device Operations

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

2/3/2025 / Artificial Intelligence , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Policy Updates , Regulatory Oversight , Regulatory Requirements , Trump Administration , World Health Organization

HHS Limits FDA Oversight of LDTs Without Formal Rulemaking, Including During COVID-19 Pandemic

The US Department of Health and Human Services (HHS) on August 19 published a sweeping announcement, Rescission of Guidances and Other Informal Issuances Concerning Premarket Review of Laboratory Developed Tests, in which it...more

8/31/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Infectious Diseases , Laboratory Developed Tests , Life Sciences , Policy Statement , Regulatory Oversight

FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments

The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more

7/20/2020 / Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Inspections , Life Sciences , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Supply Chain

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