FDA Issues Guideline
The guideline issued by the FDA is regulatory flexibility, including a temporary waiver of the premarket notification requirements under Section 510 (k) of the Food, Drug, and Cosmetic Act.
For some class I product types for which the 510 (k) test was temporarily waived during the PHE (Public Health Emergency), the Department of Health and Human Services permanently exempts the following 7 class I product 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 a further 83 class II product types and one unclassified product type from the 510 (k) requirement, for which the pre-market testing was also waived during the PHE.
→ Follow the link above and check the list there to see whether you are possibly affected by the simplifications. We are happy to help you with the clarification.