Medical devices
Showing 1-20 of 959 results.
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2024-06037. Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
- The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and...
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2024-05473. Medical Devices; Technical Amendments
- The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to update a citation for information collection and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The...
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2024-04275. Reproductive Health Services
- The Department of Veterans Affairs (VA) is finalizing, without changes, an interim final rule that amended VA's medical regulations to remove the exclusion on abortion counseling in the medical benefits package; establish exceptions to the exclusion on...
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2024-03255. North Korea Sanctions Regulations
- The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the North Korea Sanctions Regulations to modify a general license that authorizes certain transactions in support of specified humanitarian activities of...
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2024-03127. Beneficiary Travel and Special Mode Transportation Under 38 U.S.C. 111 Within the United States
- This final rule corrects the approved Office of Management and Budget (OMB) Control Number relating to collection of information under the Department of Veterans Affairs (VA) regulations that govern beneficiary travel.
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2024-01106. Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue; Confirmation of Effective Date
- The Food and Drug Administration (FDA or we) is confirming the effective date of December 4, 2023, for the final rule that appeared in the Federal Register of November 3, 2023, and that amended the color additive regulations to provide for the safe use...
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2023-28152. Medicare Program: Appeal Rights for Certain Changes in Patient Status
- This proposed rule would implement an order from the Federal district court for the District of Connecticut in Alexander v. Azar that requires HHS to establish appeals processes for certain Medicare beneficiaries who are initially admitted as hospital...
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2023-26209. Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes
- The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings;...
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2023-26208. Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials
- The Food and Drug Administration (FDA, Agency, or we) is proposing to require the filing of a premarket approval application (PMA) for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes...
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2023-24293. Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health ...
- This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for calendar year 2024 based on our continuing experience with these...
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2023-24184. Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid ...
- This major final 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 value of services, and changes...
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2023-24717. Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
- The Food and Drug Administration (FDA, Agency, or we) is classifying the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions into class II (special controls). The special controls that apply to...
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2023-24352. Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue
- The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice...
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2023-21662. Medical Devices; Laboratory Developed Tests
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2023-14624. Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid ...
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2023-14768. Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Rural Health Clinics, Federally Qualified Health Centers, ...
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2023-10827. Standards for Accessible Medical Diagnostic Equipment
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2023-07528. Copayment Exemption for Indian Veterans
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2023-06954. Copayment Exemption for Indian Veterans
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2023-06565. Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures