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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
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) TestingRule2017-2281310/20/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThis final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.clinical-laboratory-improvement-amendments-of-1988-clia-fecal-occult-blood-fob-testingFR-Doc-2017-22813
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
Changes to the In-Bond ProcessRule2017-2049509/28/2017DEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentThis final rule adopts, with several changes, proposed amendments to U.S. Customs and Border Protection (CBP) regulations regarding changes to the in-bond process published in the Federal Register on February 22, 2012. The in-bond proc … This final rule adopts, with several changes, proposed amendments to U.S. Customs and Border Protection (CBP) regulations regarding changes to the in-bond process published in the Federal Register on February 22, 2012. The in-bond process allows imported merchandise to be entered at one U.S. port of entry without appraisement or payment of duties and transported by a bonded carrier to another U.S. port of entry or other authorized destination provided all statutory and regulatory conditions are met. At the destination port, the merchandise is entered or exported. The changes in this rule, including the automation of the in-bond process, will enhance CBP's ability to regulate and track in-bond merchandise and ensure that in- bond merchandise is properly entered or exported. This document addresses comments received in response to the proposed rule and makes several changes in response to the comments that further simplify and facilitate the in-bond process.changes-to-the-in-bond-processFR-Doc-2017-20495
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
Electronic Information for Cargo Exported From the United States; Technical AmendmentsRule2017-1454907/13/2017DEPARTMENT OF HOMELAND SECURITYHomeland Security DepartmentThis final rule amends U.S. Customs and Border Protection regulations regarding the requirements to provide data for certain exported cargo to conform to current requirements. Various CBP regulations regarding exported cargo refer to o … This final rule amends U.S. Customs and Border Protection regulations regarding the requirements to provide data for certain exported cargo to conform to current requirements. Various CBP regulations regarding exported cargo refer to outdated regulations or requirements of the U.S. Census Bureau, including the requirement to submit a paper Shipper's Export Declaration (SED). The U.S. Census Bureau's Foreign Trade Regulations (FTR) have been amended to eliminate the SED and to require that the information that was previously provided on the paper SED be filed electronically through the Automated Export System. This rule amends the CBP regulations to incorporate the current requirements. The rule also makes related conforming changes as well as non-substantive editorial and nomenclature changes.electronic-information-for-cargo-exported-from-the-united-states-technical-amendmentsFR-Doc-2017-14549
Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Delay of Effective DateRule2017-1434707/10/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThis final rule delays the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017 (82 FR 4504). The publ … This final rule delays the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017 (82 FR 4504). The published effective date for the final rule was July 13, 2017, and this rule delays the effective date for an additional 6 months until January 13, 2018. This final rule also includes two conforming changes to dates that are included in the regulations text.medicare-and-medicaid-programs-conditions-of-participation-for-home-health-agencies-delay-ofFR-Doc-2017-14347
Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Delay of Effective DateProposed Rule2017-0654004/03/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThis proposed rule would delay the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017. The current … This proposed rule would delay the effective date for the final rule entitled ``Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies'' published in the Federal Register on January 13, 2017. The current effective date for the final rule is July 13, 2017, and this rule proposes to delay the effective date for an additional 6 months until January 13, 2018. This proposed rule would also make two conforming changes to dates that are included in the regulations text.medicare-and-medicaid-programs-conditions-of-participation-for-home-health-agencies-delay-ofFR-Doc-2017-06540
Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Certain Schedule II Drugs to the Department of Transportation's Drug-Testing Panel and Certain Minor AmendmentsProposed Rule2017-0113101/23/2017DEPARTMENT OF TRANSPORTATIONTransportation DepartmentThe Department of Transportation is proposing to amend its drug-testing program regulation to add four opioids (hydrocodone, hydromorphone, oxymorphone, and oxycodone) to its drug-testing panel; add methylenedioxyamphetamine (MDA) … The Department of Transportation is proposing to amend its drug-testing program regulation to add four opioids (hydrocodone, hydromorphone, oxymorphone, and oxycodone) to its drug-testing panel; add methylenedioxyamphetamine (MDA) as an initial test analyte; and remove methylenedioxyethylamphetamine, (MDEA) as a confirmatory test analyte. The proposed revision of the drug-testing panel is intended to harmonize with the revised Mandatory Guidelines established by the U.S. Department of Health and Human Services for Federal drug-testing programs for urine testing. This proposal also adds clarification to certain drug-testing program provisions where necessary, removes outdated information in the regulations that is no longer needed, and proposes to remove the requirement for employers and Consortium/Third Party Administrators to submit blind specimens.procedures-for-transportation-workplace-drug-and-alcohol-testing-programs-addition-of-certainFR-Doc-2017-01131
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