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- Public Inspection
Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program
This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare, Medicaid, Basic Health Program, and Exchange beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the coronavirus disease 2019 (COVID-19). Recognizing the critical...
21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program
This final rule implements certain provisions of the 21st Century Cures Act, including Conditions and Maintenance of Certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and...
Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the 2019 Novel Coronavirus (COVID-19). Recognizing the urgency of this situation, and understanding that some...
The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in the lists published on April 13, 2017, and July 11, 2017. FDA published a final amendment, final order in the Federal Register of December 30, 2019...
Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
The Food and Drug Administration (FDA or Agency) is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls),...
Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests
The Food and Drug Administration (FDA or Agency) is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new...