Rulemaking

Recently Posted FDA Rules and Notices.

🏛 Food and Drug Administration (FDA)FDA_FRDOC_0001

Government Governance & Reform Healthcare Costs & Access Pharmaceutical Policy Product Safety & Recalls Public Health Infrastructure & Data

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Rules, notices, and supporting material — the primary rule pinned first.

All 13 Rule 7 Notice 6

📄 Primary document

RuleJun 26, 2026

Medical Devices: Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms

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Rule· Jun 26, 2026
Medical Devices: Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome→
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Rule· Jun 26, 2026
Medical Devices: Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test→
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Rule· Jun 26, 2026
Medical Devices: General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant→
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Rule· Jun 26, 2026
Medical Devices: Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia→
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Rule· Jun 26, 2026
Medical Devices: General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System→
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Rule· Jun 26, 2026
Medical Devices: General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System→
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Notice· Jun 26, 2026
Emergency Use Authorization: In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Revocation→
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Notice· Jun 26, 2026
List of Bulk Drug Substances for which there Is a Clinical Need the Federal Food, Drug, and Cosmetic Act→
Closed on May 2, 2026
Notice· Jun 26, 2026
Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness: Rectiv (Nitroglycerin) Ointment, 0.4 Percent→
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Notice· Jun 26, 2026
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→
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Notice· Jun 26, 2026
Determination That Prednisolone Tablet, 5 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness→
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Notice· Jun 26, 2026
Agency Information Collection Activities; Proposed Collection; Comment Request; Time and Extent Applications for Nonprescription Drug Products→
Open · 23 days left