We are urging the FDA to update female condom regulations and make new options possible.
While a variety of female condoms are safe, effective, and available in a number of countries, people in the U.S. have just one option. This lack of variety is due in large part to an outdated FDA classification of the female condom.
Since approved by the FDA in the mid-1990s, the female condom has shared the same classification as breast implants and pacemakers, Class III, while male condoms enjoy a Class II status. The more stringent classification made sense when female condoms were new and data was limited. However, the establishment of quality standards and 20 years of safety and efficacy data support making female condoms a Class II device. Reclassification will remove unnecessary barriers female condom innovators face when attempting to bring new safe and effective products to market. With fewer regulatory hurdles, new female condom products may reach the market quicker and provide more options for consumers.
Get involved! Tell the FDA to pave the way for more female condom options and reclassify female condoms.
- Start the conversation about the future of female condoms on Facebook and Twitter. Use these messages to spread the word and inspire action.
- Take your picture with our photo petition and share on social media.
- Build a movement of female condom advocates by collecting petitions at community events and meetings. Get tips for community outreach here. We will deliver the petitions to the FDA offices in Washington D.C. in September as part of our Global Female Condom Day advocacy. Download the petition here.
- Read joint comments signed by 89 organizations and submitted to FDA June 26, 2015 urging female condom down-classification.
- Read the NFCC’s letter to the FDA urging down-classification.