The Food and Drug Administration (FDA) recently issued General Correspondence Letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories “after discovering data that was falsified or otherwise...more
On August 19, 2024, the Association for Molecular Pathology (AMP) sued the FDA to challenge a new rule that allows the FDA to regulate laboratory developed tests (LDTs). The rule, which became effective on July 5, 2024,...more
On April 29, 2023, the FDA announced a final rule on regulation of laboratory developed tests (LDTs). The rule explicitly categorizes in vitro diagnostic products (IVDs) intended for clinical use as medical devices, which are...more
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more
4/3/2023
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Marketing Authorization Application ,
Medical Devices ,
Pharmaceutical Industry ,
Public Health Emergency
Boston Scientific announced on August 15, 2022, that it acquired Obsidio, Inc. for an undisclosed fee. Obsidio has technology called the Gel Embolic Material (GEM™), which is used in minimally invasive blood vessel...more