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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