medical-devices

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TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
TitleActionFR DocPublishedAgencyAgency NameExcerptsAbstractHTMLPDF
Listing of Color Additives Exempt From Certification; Calcium CarbonateRule2017-2419411/07/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response … The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.listing-of-color-additives-exempt-from-certification-calcium-carbonateFR-Doc-2017-24194
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test SystemRule2017-2416111/07/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test system into class II (special controls). The special controls that apply to the device type are identified in … The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry 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 total 25-hydroxyvitamin D mass spectrometry 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-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-totalFR-Doc-2017-24161
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
General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction DeviceProposed Rule2017-2419111/07/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA) is issuing this proposed order to reclassify the needle destruction device, renaming the device to ``sharps needle destruction device,'' a postamendments class III device (regulated under prod … The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the needle destruction device, renaming the device to ``sharps needle destruction device,'' a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.general-hospital-and-personal-use-devices-reclassification-of-sharps-needle-destruction-deviceFR-Doc-2017-24191
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; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test SystemRule2017-2349110/30/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the acute kidney injury 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 c … The Food and Drug Administration (FDA or we) is classifying the acute kidney injury 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 acute kidney injury 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-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-acuteFR-Doc-2017-23491
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; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring SystemRule2017-2351610/30/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system into class II (special controls). The special controls that apply to the device typ … The Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring 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 non-EEG physiological signal based seizure monitoring 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-neurological-devices-classification-of-the-non-electroencephalogram-physiologicalFR-Doc-2017-23516
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; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test SystemRule2017-2259010/18/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the organophosphate 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 codif … The Food and Drug Administration (FDA or we) is classifying the organophosphate 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 organophosphate 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-clinical-chemistry-and-clinical-toxicology-devices-classification-of-theFR-Doc-2017-22590
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; Gastroenterology-Urology Devices; Classification of the Enzyme Packed CartridgeRule2017-2228610/16/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge 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 enzyme packed cartridge 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 enzyme packed cartridge'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-gastroenterology-urology-devices-classification-of-the-enzyme-packed-cartridgeFR-Doc-2017-22286
Medical Devices; Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue AblationRule2017-2107410/02/2017DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth and Human Services DepartmentThe Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The special controls that apply to the device type are identified in thi … The Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation 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 high intensity ultrasound system for prostate tissue ablation'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-gastroenterology-urology-devices-classification-of-the-high-intensity-ultrasoundFR-Doc-2017-21074
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