Accelerating Human Immunodeficiency Virus Self-Testing in the United States: A Call to Action

Area of Science:

• Public Health
• Medical Devices
• Infectious Disease Control

Background:

• Human immunodeficiency virus (HIV) self-testing is a key strategy to increase the number of individuals aware of their HIV status.
• Global access to HIV self-tests has expanded through public-private partnerships, particularly in low- and middle-income countries.
• Despite initial approval in 2012, no new HIV self-test applications have been submitted to the US Food and Drug Administration (FDA) in ten years.

Purpose of the Study:

• To examine the potential advantages of reclassifying HIV self-tests.
• To advocate for a regulatory change from class III to class II for HIV self-tests.
• To encourage further innovation and accessibility in HIV self-testing technology.

Main Methods:

• Review of historical FDA approval data for HIV self-tests.
• Analysis of regulatory pathways for medical devices.
• Discussion of the implications of device reclassification on market access and public health.

Main Results:

• HIV self-tests were first approved by the FDA in 2012.
• A decade-long gap in new FDA applications for HIV self-tests exists.
• Reclassification to class II may streamline the approval process.

Conclusions:

• Reclassifying HIV self-tests from class III to class II presents significant potential benefits.
• This regulatory shift could foster greater innovation and wider availability of HIV self-testing tools.
• Facilitating access to HIV self-tests is crucial for global HIV prevention and control efforts.