FDA – 510(k) Guideline for Simplification

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.



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