After years of advocacy, the FDA released a proposed order on December 1, 2017 recommending reclassifying and renaming the female condom. The proposed change would:
- put this safe and effective prevention tool in the same category as male condoms
- rename and de-gender this device through renaming it the “single-use internal condom”
- expanding the indication to include using the device for protection during anal sex
Why down-classification matters: The current Class III designation of female condoms is an artifact of what was known about this prevention tool more than 20 years ago and does not reflect the body of evidence available today. It also serves as a barrier to other safe and effective products from entering the U.S. market. The latest scientific data demonstrate that female condoms are safe, effective, perform well, and needed by women and men in the U.S. and around the globe. The FDA’s proposed order is an important step forward to expanding the number of receptive-partner initiated prevention options.
What can you do?
- Click here to add your name or your organization’s name to our sign-on letter (you must sign-on by Jan. 26 to be included)
- Submit your own comments using this template (all comments due Feb. 2, 2018)
- Spread the word to your personal and professional networks
Tips for submitting your own comments:
- Submissions are due February 2, 2018. We suggest starting now and submitting early in case you run into any unforeseen glitches.
What should you say?
- Check out our template or pull talking points from the NFCC’s own letter
- Include points that uplift the benefits of internal condoms for populations you serve or are a part of, including women vulnerable to HIV, gay and bisexual men, young people, etc.
- The FDA has a tip sheet as well
When you’re ready to submit:
- Go here to the comment submission page for this proposed rule change.
- If you accidentally navigate away from the page and need to find it again at www.regulations.gov, the docket number is FDA-2017-N-6538
- Type your comment in the text box, or upload a file, such as a Word document or PDF file
- Fill out your name. Your contact information is optional.
- Indicate if you are submitting on behalf of an organization.
- Choose a category to identify yourself. Consider “academia,” “individual consumer,” “health professional,” or any category you feel best describes you.
- Click “continue” at the bottom of the page, and you’ll be able to preview your comments before final submission