The United States regulates medical products primarily through the Food and Drug Administration, which oversees drug approvals, device clearances and approvals, biologics, and digital health. FDA guidance on Software as a Medical Device, clinical decision support, and artificial intelligence shapes global practice, and federal agencies also set rules on reimbursement and health data. This page collects the US regulatory updates HealthSignal tracks across medicines, devices, and digital health, from official public sources only.
The Food and Drug Administration (FDA or we) is issuing a final rule to amend the standard of identity for pasteurized orange juice by lowering the minimum orange juice soluble solids content from 10.5[deg] to 10[deg]...
US Federal Register - FDA RulesFact Sheets Jul 16, 2026 Manufacturer Effectuation of MFP Draft Guidance for 2028 Medicare Drug Price Negotiation Medicare Drug Price Negotiation Program: Draft Guidance for Manufacturer Effectuation of the Maximum Fa...
US CMS NewsroomThis proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative ...
US Federal Register - CMS RulesClinical laboratory testing technology has advanced significantly since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations were implemented in 1992. This request for information (RFI) seeks inpu...
US Federal Register - CMS RulesPress Releases Jul 14, 2026 CMS Proposes Transformational Medicare Reforms to Expand Accountable Care, Modernize Physician Payment, and Shift from Sick Care to Healthcare CMS Proposes Transformational Medicare Reforms...
US CMS NewsroomThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Psychedelic Drugs: Considerations for Clinical Investigations." Because interest in the therapeu...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Topical Dermatologic Corticosteroids: In Vivo Bioequivalence." This guidance provides recommenda...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), ...
US Federal Register - FDA RulesThis proposed rule would revise the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) payment system for calendar year 2027 based on our continuing experi...
US Federal Register - CMS RulesThe Department of Health and Human Services (HHS), in consultation with the National Institutes of Health (NIH), is proposing to rescind the existing regulation concerning grants under the National Cancer Institute (N...
US Federal Register - HHS RulesThis proposed rule would set forth routine updates to the Medicare home health payment rates in accordance with existing statutory and regulatory requirements. In addition, this proposed rule discusses the behavior ad...
US Federal Register - CMS RulesThe Food and Drug Administration (FDA) is classifying the skin patch for treatment of hyperhidrosis into class II (special controls). The special controls that apply to the device type are identified in this order and...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the monitor for opioid induced impairment of oxygenation into class II (special controls). The special controls that apply to the device type are identified in thi...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber into class II (special controls). The special controls that apply to the device type are identified in this order and will...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA, the Agency, or we) is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing. Complete and accurate est...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the prognostic test for development or progression of preeclampsia into class II (special controls). The special controls that apply to the device type are identif...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome into class II (special controls). The special controls that apply to the device type are i...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of ...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the breast implant suction retrieval system into class II (special controls). The special controls that apply to the device type are identified in this order and w...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the foam or gel chemical sterilant/high level disinfectant into class II (special controls). The special controls that apply to the device type are identified in t...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for the treatment of fibromyalgia symptoms into class II (special controls). The special controls that apply to the devi...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the infant supine sleep system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part o...
US Federal Register - FDA RulesThis proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also proposes to update the payment rate for renal dialysis services furnished...
US Federal Register - CMS RulesThe Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Sterigenics U.S., LLC, proposing that we amend our food additive regulations to provide for the safe...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #114 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Chickens--Gallus gallu...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #113 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Felines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #110 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Porcines." This guidan...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #109 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Equines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #97 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Caprines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #95 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Bovines." This guidance...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #90 entitled "Effectiveness of Anthelmintics: General Recommendations." This guidance has been dev...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #111 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Canines." This guidanc...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #96 entitled "Effectiveness of Anthelmintics: Specific Recommendations for Ovines." This guidance ...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled "Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological P...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biol...
US Federal Register - FDA Guidance NoticesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Master Protocols for Drug and Biological Product Development." This draft guidance revises and...
US Federal Register - FDA Guidance NoticesThis request for information seeks input from the public on whether any additions or modifications are needed to the safe harbor regulations under the Federal anti-kickback statute or the exceptions to the civil monet...
US Federal Register - HHS RulesThe Food and Drug Administration (FDA) is classifying the simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the endoscopic traction device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part o...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device into class II (special controls). The special controls that apply to the device type are identified in this order ...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 ...
US Federal Register - FDA Guidance NoticesThis request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers ("PBMs") and their affiliates to inform implementation of recent legislation. It specific...
US Federal Register - CMS RulesThe Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detection capsule into class II (special controls). The special controls that apply to the device type are identified in this...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA) is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan into class II (special controls). The special controls...
US Federal Register - FDA RulesThis final rule with comment period sets forth provisions to strengthen the oversight of Medicare national accrediting organizations by addressing conflicts of interest, establishing consistent standards, processes, a...
US Federal Register - CMS RulesThis proposed rule would codify the Medicare Drug Price Negotiation Program ("Negotiation Program") and would establish certain new policies for the Negotiation Program and the Medicare Prescription Drug Benefit Progr...
US Federal Register - CMS RulesThe Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to direct the public to organizational and contact information available on the Agency's website. FDA is also revoking certain regu...
US Federal Register - FDA RulesThe Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer ...
US Federal Register - FDA Guidance Notices