Life Sciences

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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