In addition, the statistical analysis used for efficacy has been updated. It now requires bacterial log reduction studies to continue as a demonstration that an active ingredient is effective. The rules also require substances to participate in a randomized three-arm study containing:
2. Active control
3. Negative control
The statistical analysis related to the log reduction criteria for classifying consumer antiseptic rub active ingredients is also to be considered Generally Recognized as Effective (GRAE).
The FDA has also updated the following requirements for testing efficacy:
• The test product should be non-inferior to an FDA-approved antiseptic rub as active control with a 0.5 margin (log10 scale)
• Requiring the test product should be superior to the negative control by a margin of 1.5 (log10 scale)
• A minimum sample size of 100 subjects per treatment arm
• Two adequate and well-controlled clinical simulation pivotal studies for the consumer antiseptic rub indication at two separate independent laboratory facilities by independent principal investigators must be conducted
Stakeholders are now advised to make sure their products comply with the latest regulations before offering hand sanitizers onto the market in the US.
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