FDA classifies foam or gel disinfectants for medical devices as Class II
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The Food and Drug Administration has officially classified a specific type of chemical sterilant into Class II. These products are foams or gels used to clean medical instruments before they touch a patient. By placing them in this category, the FDA is setting specific safety rules that manufacturers must follow.
Why it matters: This is mostly an administrative update that clarifies how these specific cleaning products are regulated. It does not change the safety requirements but makes it slightly easier for new versions of these disinfectants to enter the market. Hospitals and clinics will continue using these products under the same general standards, but manufacturers have a clearer path to get approval for similar items.
Who it affects
- Manufacturers of medical device cleaning foams and gels
This action was taken by the Food and Drug Administration, which published this final order in the Federal Register on June 2, 2023. You should check the original document for the full list of technical testing requirements before relying on these details.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document