By Rebecca Bowers

EXECUTIVE SUMMARY

The Food and Drug Administration has reclassified the female condom from a Class III device to a Class II device, putting it in the same category as the male condom.

  • With the reclassification comes a new name — from “single-use female condom” to “single-use internal condom” — in recognition of its use in both vaginal and anal sex.
  • The only internal condom currently available in the United States, the FC2 internal condom, is sold by prescription only. For those without insurance, it also is available for purchase online through the manufacturer, and may be available for patients at health departments or clinics.

The Food and Drug Administration (FDA) has reclassified the female condom from a Class III device to a Class II device, putting it in the same category as the male condom. With the reclassification comes a new name from “single-use female condom” to “single-use internal condom” in recognition of its use in both vaginal and anal sex. What do these changes mean for the method?

Reproductive health clinicians in the United States are familiar with the FC2 internal condom, marketed by The Female Health Company, a division of Veru Healthcare of Miami. The FC2 condom is made up of a nitrile (non-latex) sheath and outer ring, with an inner ring of polyurethane. The product does not include spermicidal additives, but it contains a silicone-based lubricant on the interior and exterior.

“The renaming of the class of devices to which the FC2 belongs is important not only for the new implied indication (anal application), but also because it also helps reinforce the trend to be less dichotomous in terms of gender identity,” states Anita Nelson, MD, professor and chair of the obstetrics and gynecology department at Western University of Health Sciences in Pomona, CA. “Instead of distinguishing between ‘male’ and ‘female’ condoms, we can discuss ‘external’ and ‘internal’ condoms.”

Members of the National Female Condom Coalition (NFCC) pushed for the device’s reclassification. NFCC is a partnership of advocates, researchers, health departments, and community-based and national organizations based in the United States. By moving the device to a Class II ranking, advocates believe it will open the door for more internal condom options. The transition from a Class III to a Class II designation lessens the burden on manufacturers when seeking FDA approval for internal condom devices.

“We are thrilled to learn about these changes and so grateful for the tireless efforts of sexual health advocates across the globe who worked for years to demand greater access to this prevention method, which truly empowers people to take control of their health on their own terms,” said Sara Semelka of the AIDS Foundation of Chicago, in a press statement. The AIDS Foundation of Chicago serves as the NFCC Secretariat.

Roxanne Lewis is the program coordinator for Healthy Alternatives for Reducing the Risk for HIV Program at JWCH Institute in Los Angeles. She has provided female condom training to more than 200 health providers.

“I fought for this because I believe there is power in choice, and I was turned on every time someone said, ‘I didn’t know about [the female condom],’” said Lewis in a press statement. “The FDA made the right decision, and I hope this turns the tide for greater choice in prevention and safer-sex options.”

Why Is Reclassification Important?

The FDA categorizes medical devices into three classes based on their risks and the regulatory controls needed to assure safety and effectiveness. A Class III device requires the greatest amount of clinical evidence and control, which in turn pushes up the costs and efforts to reach premarket approval. Pacemakers and breast implants, for example, are considered Class III devices.

The male condom was ranked as a Class II device in 1981 because of the FDA’s determination that sufficient evidence existed for safety and effectiveness. However, when the FC2’s predecessor, the FC1 female condom, was evaluated in 1991, the device was not found to be “substantially equivalent” to the male condom, and subsequently received a Class III device designation.

Since the FC1’s initial approval and the FC2’s approval in 2009, additional female condom products have emerged, achieving regulatory approvals and prequalification by the World Health Organization, as well as marketing approval in other countries. Advocates say the Class III designation has deterred some female condom manufacturers from pursuing FDA approval for their products in the United States. With the reclassification, potential internal condom manufacturers no longer have to submit an application for premarket approval. Instead, companies can provide a 510(k) premarket submission to demonstrate that the device is substantially equivalent to another device that is legally marketed in the United States.

Design firm IXu of Petoskey, MI, plans to seek FDA approval in early 2019 for its VA “worn-of-women” line of internal condoms. In September 2018, the firm announced a new contract with manufacturer HLL Lifecare Ltd., a government-owned device company in India, to kick off its European sales.

Gender-neutral Name Removes Barriers

Advocates say the renaming of the female condom sets the stage for greater inclusivity, especially for the LGBTQ community. Observational studies in the United States indicate that some men who have sex with men use the female condom for anal intercourse.1-3

In its September 2018 regulatory action, the FDA made the following statement: “The device is assigned the generic name single-use internal condom, and it is identified as an OTC [over-the-counter] sheath-like device that lines the vaginal or anal wall and is inserted into the vagina or anus prior to the initiation of coitus. At the conclusion of coitus, it is removed and discarded. It is indicated for contraception and/or prophylactic (preventing the transmission of sexually transmitted infections) purposes.”4

Data indicate that anal intercourse is a common practice in the United States. Among men ages 25 to 44, 3.9% report having had anal intercourse with another man, and 40% say they have had anal intercourse with a woman. Among women ages 25 to 44, 35% report having had heterosexual anal intercourse.5 Such practice is a concern for public health officials: Unprotected anal intercourse is the sexual activity associated with the highest risk of HIV infection.6

Over-the-counter Access Underlined

The FC2 internal condom currently is sold by prescription only in the United States. For those without insurance, it also is available for purchase online through the manufacturer, and may be available for patients at health departments or clinics. The price for all public sector and 501(c)(3) entities, based on a box of 1,000, is $1.10 per device, starting Jan. 1, 2019. The Female Health Company is the only organization selling the FC2 condom directly to the U.S. public sector.

According to the FDA ruling, the single-use internal condom is designated as an over-the-counter device. Reproductive health advocates say the classification should open the door for greater access, bringing internal condoms to the drugstore shelves.

REFERENCES

  1. Gross M, Buchbinder SP, Holte S, et al. Use of Reality “female condoms” for anal sex by US men who have sex with men. HIVNET Vaccine Preparedness Study Protocol Team. Am J Public Health 1999;89:1739-1741.
  2. Renzi C, Tabet SR, Stucky JA, et al. Safety and acceptability of the Reality condom for anal sex among men who have sex with men. AIDS 2003;17:727-731.
  3. Wolitski RJ, Halkitis PN, Parsons JT, Gomez CA. Awareness and use of untested barrier methods by HIV-seropositive gay and bisexual men. AIDS Educ Prev 2001;13:291-301.
  4. Food and Drug Administration. Obstetrical and Gynecological Devices; Reclassification of single-use female condom, to be renamed single-use internal condom. 83 Fed Reg 48,711 (Sept. 27, 2018).
  5. Mosher WD, Chandra A, Jones J. Sexual behavior and selected health measures: Men and women 15-44 years of age, United States, 2002. Adv Data 2005;362:1-55.
  6. Leynaert B, Downs AM, de Vincenzi I. Heterosexual transmission of human immunodeficiency virus: Variability of infectivity throughout the course of infection. European Study Group on Heterosexual Transmission of HIV. Am J Epidemiol 1998;148:88-96.