4U Health

The United States Food and Drug Administration (FDA or the Agency) has learned that your firm, 4U Health, is offering for sale in the United States a human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kit (hereinafter, your “HIV DBS card self-collection kit”) without marketing authorization, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under section 201(h)(1) of the FD&C Act, 21 U.S.C. 321(h)(1), your HIV DBS card self-collection kit is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

FDA has reviewed your company’s website at www.4uhealth.com (last visited March 2026) and your firm’s responses to previous FDA correspondence. Based on our review of these materials, your firm offers its HIV DBS card self-collection kit for delivery to individuals and intends for these individuals to use the kit to self-collect DBS samples and ship those samples to laboratories for HIV testing. FDA has determined that your HIV DBS card self-collection kit is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B) because it does not have an approved premarket approval application (PMA) in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g). Your HIV DBS card self-collection kit is also misbranded under section 502(o) the FD&C Act, 21 U.S.C. 352(o), because notification of the intent to introduce the device into commercial distribution has not been provided to the agency, as required by section 510(k) of the FD&C Act, 21 U.S.C. 360(k).

FDA has not authorized your firm’s HIV DBS card self-collection kit for use in HIV serological diagnostic testing.

In a letter dated March 31, 2025, FDA informed you that you appeared to be offering for sale and distributing your HIV serological diagnostic self-collection kits in a manner that may violate the FD&C Act. In your response dated April 30, 2025, you assert that 4U Health “do[es] not sell self-collection testing kits,” and that 4U Health instead “facilitates access to professional medical services, including HIV testing.” You indicate that “[y]our physician consultants order” tests and “oversee the entire testing process.” And you state that the “service” you offer is “not intended to diagnose, treat, or cure any disease on its own,” as “[p]ositive results require confirmation and diagnosis by a licensed medical provider not affiliated with 4U Health.”

Express statements on your firm’s website and in your April 30, 2025 response make clear that your firm is selling and distributing HIV serological diagnostic self-collection kits. For example, your website states that the kit “will arrive in plain packaging” and “contains everything you need to collect your home sample.” And your April 30, 2025 response acknowledges that your “at-home testing collection supplies” are “provided to [y]our clients for sample collection.” As explained above, because your firm’s HIV DBS card self-collection kit is a device that has not received FDA marketing authorization, the kit is adulterated and misbranded.

Notably, this letter and the March 31, 2025 letter sent to your firm focus on your HIV serological diagnostic self-collection kits and are not intended to be a comprehensive list of potential issues with your firm’s products. Even if, as you say, any testing you conduct on samples is intended to provide only preliminary results, the kits you “source[] from independent distributors” and ship to customers for the purpose of sample collection by customers “at-home” (as stated in your April 30, 2025 response) are devices. Nor does the involvement of “physician consultants” in ordering any testing or interpreting any results mean that the collection kits you are shipping are not devices.

Without appropriate testing, data review, and marketing authorization, there is a lack of assurance of the safety and effectiveness of your HIV DBS card self-collection kit. Self-collection raises several issues of importance, including, for example, whether the user can safely and properly collect the specimen, if the sample has been properly shipped, and if there is adequate stability of the specimen given the time lapse between collection and testing and the potential impact of shipping conditions. We also note that there are FDA-approved over-the-counter HIV tests that can help meet the needs of individuals who wish to test themselves at home or who are unable to access other testing options.

The violations cited in this letter are not meant to be an all-inclusive list of violations that may exist in connection with your products. FDA requests that your firm immediately cease any activities that result in the misbranding or adulteration of your HIV DBS card self-collection kit. Your firm should take prompt action to address the violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration in your response to this letter.

Within fifteen working days of receipt of this letter, please notify FDA in writing of the specific steps that you have taken to correct any violations. Your response should include an explanation of each step being taken to prevent the recurrence of violations as well as related documentation. If you cannot complete all corrective actions within fifteen working days, state the reason for the delay and the date by which you will complete the correction.

Send your electronic response and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.