The FDA is reclassifying female condoms to make it easier for companies to bring products to market.
Female condoms are currently categorized as Class III medical devices, meaning companies must follow the premarket approval (PMA) pathway to bring them to market.
By redesignating single-use female condoms as Class II devices, the FDA will allow companies to seek the less arduous 510(k) clearance.
The market for female condoms has never taken off in the U.S. Today, only one device, Veru’s FC2, is on the market, but it's a niche, prescription-only product. One explanation for the lack of competition is the Class III regulatory status of female condoms. If a company wanted to challenge Veru for the female condom market, it would need to seek PMA. Male condoms, in contrast, are categorized as Class II devices and regulated under the 510(k) pathway.
Late last year, the FDA proposed recategorizing female condoms to reduce the regulatory burdens on companies that want to bring such products to market. Having reviewed the 78 responses to the consultation, the FDA has decided to go ahead with the recategorization. As of October 29, the FDA will categorize female condoms as Class II medical devices.
The change could encourage companies to bring female condoms to market via the 510(k) pathway. Manufacturers that take this opportunity will need to comply with certain special controls placed on the devices, though. In assessing the best path forward last year, the FDA decided companies should run contraceptive effectiveness studies to evaluate the cumulative pregnancy rate. The proposal was underpinned by a desire to “mitigate the risks to health related to pregnancy for this device type.”
Multiple respondents to the FDA’s consultation questioned the need to run these studies. However, the FDA has rejected the prospect of using clinical evidence from male condoms to mitigate the risk of female condoms.
“FDA believes that a contraceptive effectiveness study is necessary to mitigate the risk of an undesired pregnancy because internal condoms have distinct design features from male condoms and from other internal condoms that can only be evaluated through a contraceptive effectiveness study,” the agency wrote in response to the feedback it received.
The question now is whether the regulatory reclassification will lead to the introduction of more female condoms. While the regulatory barrier is coming down, the market opportunity remains uncertain. Last year Veru’s sales, most of which come from FC2, totaled $13.7 million. Veru is reliant on global public-sector customers, not U.S. consumers, for its sales.
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The setback doesn't remove hurdles the rivals face playing catch-up to market leader Intuitive's da Vinci, which has a two-decade head start.
While the European Union’s MDR went into effect in May 2021, device makers still face a range of uncertainties and potential problems one year later.
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