美国FDA加大对数十种医疗设备的510（k）永久性豁免
2021/01/15 FDA HHS
美国FDA已从510（k）上市前通知的要求中永久豁免了7种类型的低风险医疗器械，并已提议对其他几种器械采取类似的豁免措施，以在COVID-19公共卫生紧急情况下扩大对这些器械产品的使用范围。
根据FDA最近的通告，此次被宣布获得永久豁免510（k）的7种一类设备类型，包括手术用手套和检诊用手套；这些豁免已于2021年1月15日生效。
如下为上述提及的永久豁免的7种一类设备类型:
设备描述 | 类型 | 产品代码 |
Powder-Free Polychloroprene Patient Examination Glove | I | OPC |
Patient Examination Glove, Specialty | I | LZC |
Radiation Attenuating Medical Glove | I | OPH |
Powder-Free Non-Natural Rubber Latex Surgeon”s Gloves | I | OPA |
Powder-Free Guayle Rubber Examination Glove | I | OIG |
Latex Patient Examination Glove | I | LYY |
Vinyl Patient Examination Glove | I | LYZ |
此外，由于没有充分报告数据证明部分设备的不良事件，FDA提议永久豁免83种二类设备以及一种未分类设备的510（k）注册要求。并针对83种二类设备以及一种未分类设备上市前通知要求的豁免拟定了60天的征求意见期。
如下为上述提及的被提议永久豁免的83种二类设备以及一种未分类设备:
设备描述 | 类型 | 产品代码 |
Ventilator, Continuous, Minimal Ventilatory Support, Home Use | II | NQY |
Airway Monitoring System | II | OQU |
Impedance Measuring Device Utilizing Oscillation Techniques | II | PNV |
Gauge, Pressure, Coronary, Cardiopulmonary Bypass | II | DXS |
Valve, Pressure Relief, Cardiopulmonary Bypass | II | MNJ |
Oximeter, Tissue Saturation, Reprocessed | II | NMD |
Multivariate Vital Signs Index | II | PLB |
Electrocardiograph Software For Over-The-Counter Use | II | QDA |
Sterilizer, Dry Heat | II | KMH |
Check Valve, Retrograde Flow (In-Line) | II | MJF |
Intravascular Administration Set, Automated Air Removal System | II | OKL |
Neuraxial Administration Set—Intrathecal Delivery | II | PYR |
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | II | PSW |
Pediatric/Child Facemask | II | OXZ |
Normalizing Quantitative Electroencephalograph Software | II | OLU |
Computerized Cognitive Assessment Aid | II | PKQ |
Physiological Signal Based Seizure Monitoring System | II | POS |
Computerized Behavioral Therapy Device For Psychiatric Disorders | II | PWE |
Monitor, Phonocardiographic, Fetal | II | HFP |
Monitor, Cardiac, Fetal | II | KXN |
Digital Pathology Display | II | PZZ |
Digital Pathology Image Viewing And Management Software | II | QKQ |
System, Imaging, Holography, Acoustic | II | NCS |
Lung Computed Tomography System, Computer-Aided Detection | II | OEB |
Chest X-Ray Computer Aided Detection | II | OMJ |
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | II | POK |
Radiological Computer-Assisted Triage And Notification Software | II | QAS |
Radiological Computer Assisted Detection/Diagnosis Software For Fracture | II | QBS |
Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer | II | QDQ |
Radiological Computer-Assisted Prioritization Software For Lesions | II | QFM |
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | II | QHA |
Automated Radiological Image Processing Software | II | QIH |
Image Acquisition And/Or Optimization Guided By Artificial Intelligence | II | QJU |
Apparatus, Vestibular Analysis | 未分类 | LXV |
Meter, Peak Flow, Spirometry | II | BZH |
Oximeter, Reprocessed | II | NLF |
Stethoscope, Electronic | II | DQD |
Defoamer, Cardiopulmonary Bypass | II | DTP |
Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass | II | JOD |
Detector, Bubble, Cardiopulmonary Bypass | II | KRL |
Cpb Check Valve, Retrograde Flow, In-Line | II | MJJ |
Sterilizer, Ethylene-Oxide Gas | II | FLF |
Cabinet, Ethylene-Oxide Gas Aerator | II | FLI |
Purifier, Air, Ultraviolet, Medical | II | FRA |
Cleaner, Air, Medical Recirculating | II | FRF |
Controller, Infusion, Intravascular, Electronic | II | LDR |
Cleaners, Medical Devices | II | MDZ |
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position | II | OMF |
N95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies | II | ORW |
Two Or More Sterilant Sterilizer | II | PJJ |
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist | II | OUJ |
Surgical Mask With Antimicrobial/Antiviral Agent | II | OUK |
Cerebral Oximeter | II | QEM |
Device, Sleep Assessment | II | LEL |
Standard Polysomnograph With Electroencephalograph | II | OLV |
Source Localization Software For Electroencephalograph Or Magnetoencephalograph | II | OLX |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph | II | OLZ |
Amplitude-Integrated Electroencephalograph | II | OMA |
Automatic Event Detection Software For Full-Montage Electroencephalograph | II | OMB |
Burst Suppression Detection Software For Electroencephalograph | II | ORT |
Transducer, Ultrasonic, Obstetric | II | HGL |
Tonometer, Ac-Powered | II | HKX |
Tonometer, Manual | II | HKY |
Automated Digital Image Manual Interpretation Microscope | II | OEO |
Analyzer, Medical Image | II | MYN |
C-Arm Fluoroscopic X-Ray System | II | RCC |
Cannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection | II | NCP |
Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | II | NZJ |
Sterilizer Automated Loading System | II | PEC |
Infusion Safety Management Software | II | PHC |
Gown, Isolation, Surgical | II | FYC |
Whole Slide Imaging System | II | PSY |
Oxygenator, Long Term Support Greater Than 6 Hours | II | BZG |
Subcutaneous Implanted Apheresis Port | II | QAV |
Non-Coring (Huber) Needle | II | BYS |
Hood, Surgical | II | MAJ |
N95 Respirator With Antimicrobial/Antiviral Agent | II | OKC |
Monitor, Uterine Contraction, External (For Use In Clinic) | II | PTI |
Coil, Magnetic Resonance, Specialty | II | PWH |
Oxygenator, Long Term Support Greater Than 6 Hours | II | FXY |
Transmitters And Receivers, Electrocardiograph, Telephone | II | ONT |
Extracorporeal System For Long-Term Respiratory/Cardiopulmonary Failure | II | OMC |
Implanted Subcutaneous Securement Catheter | II | MOS |
Subcutaneous Implanted Apheresis Port | II | QHY |
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