Federal Register #FDA-2026-N-4659

FDA Classifies External Condom for Anal and Vaginal Intercourse as Class II Medical Device

This summary covers recent regulatory actions by the Food and Drug Administration (FDA) regarding medical device classification: - Government Buyer: - Food and Drug Administration (FDA), Center for Devices and Radiological Health - OEMs and Vendors: - No specific OEMs or vendors are named in the regulatory action - Global Protection Corp. is referenced as the requester for De Novo classification of the ONE Male Condom - Products/Services Requested: - External condom for anal or vaginal intercourse - Part number: 884.5305 - Quantity: Not specified (regulatory classification, not a procurement) - Description: Barrier device covering the penis, intended to prevent transmission of sexually transmitted infections (STIs) and for contraception when used for vaginal intercourse - Unique or Notable Requirements: - Device is classified as a Class II medical device with special controls - Clinical performance data demonstrating failure rates - Non-clinical performance testing for mechanical and material integrity - Biocompatibility evaluation - Shelf life testing - Specific labeling requirements, including contraceptive effectiveness tables, compatibility statements, warnings, and expiration dates - Classification excludes condoms intended solely for vaginal intercourse - Regulatory action aims to ensure safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices - Additional Context: - No procurement or contract award is involved; this is a regulatory classification action

Description

The Food and Drug Administration (FDA) is classifying the external condom for anal intercourse or vaginal intercourse into class II with special controls to ensure safety and effectiveness. This classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. The device is identified as a barrier device used to prevent transmission of sexually transmitted infections and for contraception when used for vaginal intercourse. The classification excludes condoms intended for vaginal intercourse only. Special controls include clinical performance data, non-clinical performance testing, biocompatibility evaluation, shelf life testing, and specific labeling requirements.

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