October 29, 2024
Summary of the Issue:
The Food and Drug Administration is advising the public, including consumers, health care professionals, and community-based organizations, health departments, and clinics where HIV self-testing programs are available, that HIV blood sample self-collection kits are being marketed in the United States without required FDA marketing authorization. Without appropriate regulatory review and authorization, FDA lacks assurance of the safety and effectiveness of these medical devices. Therefore, the Agency does not know whether use of these HIV blood sample self-collection kits will reliably produce valid, accurate results when samples obtained with these kits are used in HIV testing.
HIV Blood Sample Self-Collection Kit Information for Health Care Professionals and Consumers:
FDA will continue to monitor the situation closely and keep the public informed if new information becomes available.
Consumers and health care providers who have questions may contact FDA’s Center for Biologics Evaluation and Research (CBER) at: [email protected].
FDA is actively engaged with device manufacturers and interested in working with additional manufacturers towards the goal of authorizing more home use tests, tests for use with at-home sample collection, and self-collection kits for HIV detection. Manufacturers that have questions about FDA regulations may contact CBER at: [email protected].
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Content current as of:
10/29/2024
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Regulated Product(s)
Health Topic(s)
