The FDA has issued a guidance.
The guidance of FDA provides regulatory flexibility, including a temporary waiver of Premarket Notification requirements under section 510(k) of the Food, Drug, and Cosmetic Act .
For some Class I device types for which 510(k) review was temporarily waived during the PHE (Public Health Emergency) , the Department of Health and Human Services is permanently exempting the following 7 Class I device types from the 510(k) requirement:
- Powder-Free Polychloroprene Patient Examination Glove
- Patient Examination Glove, Specialty
- Radiation Attenuating Medical Glove
- Powder-Free Non-Natural Rubber Latex Surgeon”s Gloves
- Powder-Free Guayle Rubber Examination Glove
- Latex Patient Examination Glove
- Vinyl Patient Examination Glove
It is also proposed to exempt an additional 83 Class II device types and one unclassified device type from the 510(k) requirement, for which premarket review was also waived during the PHE .
→ Follow the link above and check the list there to see whether you may be affected by the simplifications. We will be happy to help you clarify this.
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