Devices

FDA Warns HIV Testing Companies on Collection Devices

FDA’s recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of unauthorized at-home blood collection devices underscores that self-collection kits remain subject to FDA oversight despite a recent court ruling that curtailed the agency’s authority over laboratory-developed tests (LDTs), an Akin legal update says.

In Warning Letters released last week, the agency cited Genetrace, Genovate, Germaphobix and ProDx Health for selling HIV testing services that rely on self-collection kits containing dried blood spot (DBS) cards. The companies market the tests directly to consumers, allowing individuals to collect blood samples at home and mail them to laboratories for analysis.

According to FDA, the DBS cards used in these kits are medical devices that lack agency authorization for use as self-collection devices. As a result, the agency said the products are being marketed in violation of federal law.

The enforcement action comes after a major legal setback for FDA in 2025 when the U.S. District Court for the Eastern District of Texas vacated the agency’s final rule asserting authority to regulate LDTs as medical devices, the Akin update notes. That rule was intended to resolve a long-running debate over the FDA’s role in overseeing tests developed and performed by clinical laboratories.

Despite the court decision, FDA has maintained that its enforcement discretion for LDTs does not extend to specimen collection devices. In the preamble to the now-vacated LDT rule, the agency stated that collection devices used with LDTs remain subject to medical device regulation.

The newly disclosed Warning Letters reaffirm that position, signaling that the FDA will continue to pursue compliance actions against companies that market self-collection devices without authorization, Akin says. The agency has previously taken similar action, issuing a Warning Letter in 10/2024 to another company offering an HIV DBS self-collection kit, before the court struck down the LDT rule, it adds.

The actions suggest that, even in the absence of the LDT rule, FDA scrutiny of direct-to-consumer testing — particularly where at-home specimen collection is involved — will likely continue in 2026.

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