Biomedical Research

Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation

Medical Devices: Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome

List of Bulk Drug Substances for which there Is a Clinical Need the Federal Food, Drug, and Cosmetic Act

Medical Devices: Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test

Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Rectiv (Nitroglycerin) Ointment, 0.4 Percent

Medical Devices: General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant

Medical Devices: Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia

Medical Devices: General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System

Medical Devices: General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Syntest D.S. and Syntest H.S. Tablets; Withdrawal of Hearing Requests; Final Resolution of Drug Efficacy Study Implementation 7661

Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness

Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products