对于因COVID期限而临时免除提交510(k)的7个Class I机器实施永久豁免。
在COVID期间引起的PHE状况中，暂时免除提交510(k)，
有7个Class I产品群将永久免除提交。
由于COVID期间为快速提供医疗产品的暂时性决定变为永久性豁免的积极性事件，
具体范围对象如下所示。
| Device description | Device class | Product code | Section in 21 CFR |
| Powder-Free Polychloroprene Patient Examination Glove | I | OPC | 880.6250 |
| Patient Examination Glove, Specialty | I | LZC | 880.6250 |
| Radiation Attenuating Medical Glove | I | OPH | 880.6250 |
| Powder-Free Non-Natural Rubber Latex Surgeon”s Gloves | I | OPA | 878.4460 |
| Powder-Free Guayle Rubber Examination Glove | I | OIG | 880.6250 |
| Latex Patient Examination Glove | I | LYY | 880.6250 |
| Vinyl Patient Examination Glove | I | LYZ | 880.6250 |
与此同时，建议对完全没有有害报告事例和副作用为最小限度的83个Class II
及未进行等级分类的产品群进行追加豁免。
作为豁免对象的医疗器械可在下方链接中进行确认。
Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devi
To provide Americans with expanded access to certain medical devices to respond to the COVID-19 Public Health Emergency, FDA issued guidance documents providing numerous regulatory flexibilities, including a temporary waiver of premarket notification requi
www.federalregister.gov
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