FDA issues special control guidance for condoms
Device Regulation Alert: Safety, Compliance and Reimbursement News, November 24, 2008
The FDA outlines labeling recommendations for natural rubber latex condoms without spermicidal lubricant, a Class II device, in a special control guidance.
The special controls guidance document:
- Provides the classification and product code for latex condoms
- Includes examples of recommended labeling
- Outlines the areas that require special control and recommends mitigation measures
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