biologics

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TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment SystemRule2017-2415911/07/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and … The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the genetic health risk assessment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-genetic-health-riskFR-Doc-2017-24159
Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection SystemRule2017-2416211/07/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This … The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.medical-devices-exemption-from-premarket-notification-class-ii-devices-autosomal-recessive-carrierFR-Doc-2017-24162
Medical Devices; Immunology and Microbiology Devices; Classification of the BCR-ABL Quantitation TestRule2017-2374211/01/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the BCR-ABL quantitation 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 the codifi … The Food and Drug Administration (FDA or we) is classifying the BCR-ABL quantitation 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 the codified language for the BCR-ABL quantitation test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-bcr-abl-quantitation-testFR-Doc-2017-23742
Medical Devices; Immunology and Microbiology Devices; Classification of the Streptococcus SPP. Nucleic Acid-Based AssayRule2017-2351310/30/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the Streptococcus spp. nucleic acid-based assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be p … The Food and Drug Administration (FDA or we) is classifying the Streptococcus spp. nucleic acid-based assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Streptococcus spp. nucleic acid-based assay's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-streptococcus-spp-nucleicFR-Doc-2017-23513
Medical Devices; Immunology and Microbiology Devices; Classification of the Aquaporin-4 Autoantibody Immunological Test SystemRule2017-2348910/30/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and … The Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Aquaporin-4 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-aquaporin-4-autoantibodyFR-Doc-2017-23489
Medical Devices; Immunology and Microbiology Devices; Classification of the Newborn Screening Test for Severe Combined Immunodeficiency DisorderRule2017-2349610/30/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls). The special controls that apply to the device type are ident … The Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the newborn screening test for SCID's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-newborn-screening-test-forFR-Doc-2017-23496
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected SepsisRule2017-2299410/24/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). … The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non- microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-andFR-Doc-2017-22994
Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of MicroorganismsRule2017-2302210/24/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms into class II (special controls). The special controls that apply to the device type are … The Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the mass spectrometer system for clinical use for the identification of microorganisms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-mass-spectrometer-systemFR-Doc-2017-23022
Medical Devices; Immunology and Microbiology Devices; Classification of the Zinc Transporter 8 Autoantibody Immunological Test SystemRule2017-2299510/24/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the zinc transporter 8 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order … The Food and Drug Administration (FDA or we) is classifying the zinc transporter 8 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the zinc transporter 8 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-zinc-transporter-8FR-Doc-2017-22995
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal FluidRule2017-2276910/20/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device … The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-andFR-Doc-2017-22769
Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood SpecimensRule2017-2228710/16/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II (special con … The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-nucleic-acid-based-deviceFR-Doc-2017-22287
Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture MediaRule2017-2230510/16/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the automated image assessment system for microbial colonies on solid culture media into class II (special controls). The special controls that apply to the device type are … The Food and Drug Administration (FDA or we) is classifying the automated image assessment system for microbial colonies on solid culture media into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated image assessment system for microbial colonies on solid culture media's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.medical-devices-immunology-and-microbiology-devices-classification-of-the-automated-image-assessmentFR-Doc-2017-22305
Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology AssaysRule2017-1585807/27/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are ident … The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.medical-devices-immunology-and-microbiology-devices-classification-of-the-assayed-quality-controlFR-Doc-2017-15858
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention ProgramProposed Rule2017-1463907/21/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThis major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies.This major proposed rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies.medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisionsFR-Doc-2017-14639
Medicare Program; CY 2018 Updates to the Quality Payment ProgramProposed Rule2017-1301006/30/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced … The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This rule provides proposed updates for the second and future years of the Quality Payment Program.medicare-program-cy-2018-updates-to-the-quality-payment-programFR-Doc-2017-13010
July 2017 Revision of Patent Cooperation Treaty ProceduresRule2017-1087005/26/2017DEPARTMENT OF COMMERCECommerce DepartmentThe United States Patent and Trademark Office (USPTO or Office) is amending the rules of practice to implement certain amendments made to the Regulations under the Patent Cooperation Treaty (PCT) that will take effect on July 1, 2 … The United States Patent and Trademark Office (USPTO or Office) is amending the rules of practice to implement certain amendments made to the Regulations under the Patent Cooperation Treaty (PCT) that will take effect on July 1, 2017, concerning the transmittal by a Receiving Office to an International Searching Authority of documents relating to an earlier search or classification.july-2017-revision-of-patent-cooperation-treaty-proceduresFR-Doc-2017-10870
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination NoticesProposed Rule2017-0780004/28/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentWe are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these system … We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these proposed changes would implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making proposals relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the proposed estimated market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are proposing to establish new requirements or revise existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are proposing to update policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are proposing changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-theFR-Doc-2017-07800
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins and Enhanced Biosafety RequirementsRule2017-0072601/19/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentIn accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services … In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Response Act), the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. Following the review, HHS has decided: Not to finalize the proposed changes to the list of select agents and toxins at this time; to finalize provisions to address toxin permissible limits and the inactivation of select agents; to finalize specific provisions to the section of the regulations addressing biosafety; and to clarify regulatory language concerning security, training, incident response, and records. In a companion document published in this issue of the Federal Register, the U.S. Department of Agriculture (USDA) has made parallel regulatory changes.possession-use-and-transfer-of-select-agents-and-toxins-biennial-review-of-the-list-of-select-agentsFR-Doc-2017-00726
National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury TableRule2017-0070101/19/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentOn July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program ( … On July 29, 2015, the Secretary of Health and Human Services (the Secretary) published in the Federal Register a Notice of Proposed Rulemaking (NPRM) to amend the regulations governing the National Vaccine Injury Compensation Program (VICP or program) by proposing revisions to the Vaccine Injury Table (Table). The Secretary based the Table revisions primarily on the 2012 Institute of Medicine (IOM) report, ``Adverse Effects of Vaccines: Evidence and Causality,'' the work of nine HHS workgroups who reviewed the IOM findings, and consideration of the Advisory Commission on Childhood Vaccines' (ACCV) recommendations. The Secretary amends the Table through the changes in this final rule. These changes will apply only to petitions for compensation under the VICP filed after this final rule becomes effective.national-vaccine-injury-compensation-program-revisions-to-the-vaccine-injury-tableFR-Doc-2017-00701
Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical SpecimensRule2017-0019901/12/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenz … The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.microbiology-devices-reclassification-of-influenza-virus-antigen-detection-test-systems-intended-forFR-Doc-2017-00199
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