FDA proposes to re-classify the female condom

​Were you aware the FDA classifies male condoms as a more favorable health device than internal condoms, traditionally known as “female condoms?” While women continue to overcome systemic barriers society set, another area where challenges remain is healthcare – especially concerning tools available to empower women.
 
After years of advocates lobbying, the Food and Drug Administration (FDA) is now considering a rule change on how the “female” condom is classified by the FDA. The National Female Condom Coalition (NFCC) is advocating that it be changed from a Class 3 medical device to a Class 2, the same class as the male condom, which requires less research, testing, and development.
 
The current classification is crippling the female condom industry, but a reclassification provides opportunity for the research and implementation of new and developing products to enter the U.S. that are already recognized by the World Health Organization (WHO) and on the market in other countries (such as Africa, Brazil, and throughout Europe).
 
NFCC is also aiming for the device to be renamed as the “internal condom.” The hope is that by changing its name, the indication of the device’s use would be broadened to include anal sex, automatically expanding how it can be used by different populations – a huge win in the fight against HIV/AIDS.
 
Now that there’s some movement for the rule to be adapted, the FDA’s Subcommittee on Medical Devises is accepting public comment until Feb. 2, which will be considered during their deliberation. Advocates are asking the public to submit their own comments, which can come from individuals, organizations, healthcare professionals, advocates, women’s health/family planning experts, the general public, or anyone interested in the discussion. Specific ways individuals can help are outlined here: nationalfccoalition.org/fda-campaign