A Sensor for Every Symptom: FDA Puts $1.1 Million Behind Digital Health in Drug Trials

On July 20, 2026, FDA posted a funding opportunity for sponsors putting digital health technologies (DHTs) to work in clinical trials. RFA-FD-26-012 is a U01 cooperative agreement with a $1.1 million award ceiling, two expected awards, and no cost-sharing requirement (Assistance Listing 93.103). Applications close August 20, 2026.

The subject is DHTs, including actigraphy, photography, and contactless sensors, used for remote data acquisition in clinical investigations that support drug and biological product development. FDA lists four areas of interest (but notes the scope is non-exhaustive):

• Comparing digital measurements to traditional measurements in clinical trials evaluating drugs;
• Developing and evaluating novel endpoints using DHTs, such as contactless room sensors that capture apnea in pediatric patients;
• Comparing metrics to evaluate continuous measurements, such as maximum activity and stamina; and
• Capturing early manifestations of chronic disease, such as non-memory related signs of dementia detected through tests of balance or slowed reaction time.

The Clinical Trials Optional designation in the announcement title widens the applicant pool. Under NIH policy, that designation permits an applicant to propose a clinical trial without requiring one, so a sponsor running a measurement comparison or endpoint development project with no trial underway remains eligible.

FDA asked the public about this subject four months ago. Its March 2026 Request for Information sought comment on advancing DHT use in clinical investigations for drugs and biological products, with comments closing June 1. The Agency is now funding the work directly, consistent with CDER and CBER commitments under PDUFA VII to support DHT use in drug and biological product development.

Eligibility is broad: small businesses, other for-profit organizations, public and private institutions of higher education, nonprofits, and a range of state, local, and tribal government entities all qualify, which opens the door to sponsor-academic collaborations. The cooperative agreement structure carries an obligation a grant would not. A federal agency uses that instrument when substantial involvement is expected between the agency and the recipient in carrying out the funded activity. 31 U.S.C. § 6305(2). For a sponsor seeking early FDA alignment on measurement strategy, that involvement is the attraction. For a sponsor guarding a proprietary algorithm and a fixed development timeline, it is a cost. Two anticipated awards make the competition demanding either way.

Sponsors weighing an application before August 20 should do two things now. First, confirm federal registrations. Submission through Grants.gov requires an active SAM.gov entity registration, and HHS opportunities issued through the NIH Guide also require an eRA Commons account. NIH recommends starting that process six weeks before a deadline, which exceeds the time remaining for an organization beginning from zero. Second, determine whether the DHT meets the definition of a device, since the answer shapes the application and everything downstream of it.

The device answer changes what the application must contain. If the DHT is a device, its use in the proposed investigation becomes a regulated activity for which the protocol has to account: a significant risk determination sets which requirements attach, and a sponsor relying on another company’s DHT may need a right of reference to the manufacturer’s device master file to describe the technology. If the DHT is not a device, none of that applies, and the proposal advances on the drug or biologic pathway alone. Answering the question before drafting keeps a sponsor from building a budget and timeline around the wrong pathway.

FDA’s December 2023 final guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, tells a sponsor what to do once its DHT is a device: when an investigational device exemption applies, and when information already in an IND suffices. It does not tell the sponsor whether the DHT is a device. The guidance puts that question, whether a DHT meets the definition in FDC Act § 201(h) (21 U.S.C. § 321(h)), expressly outside its scope. The FDA Law Blog covered the guidance when it issued.

The 21st Century Cures Act excluded five categories of software function from the device definition at FDC Act § 520(o)(1) (21 U.S.C. § 360j(o)(1)), and § 520(o)(2) governs products that combine device and non-device functions. FDA moved that line twice in January 2026, revising both the Clinical Decision Support Software guidance, which interprets § 520(o)(1)(E), and the General Wellness: Policy for Low Risk Devices guidance, which now extends enforcement discretion to noninvasive wearables that sense or estimate physiologic parameters where the claims stay within wellness. Because the exclusions depend on function rather than product, one DHT can split: a regulated sensor paired with an unregulated app, or an unregulated sensor feeding software that analyzes the signal and becomes a regulated device. A sponsor should classify each function separately. Under § 520(o)(2), FDA does not regulate an excluded software function as a device merely because it is packaged with a device function, though in reviewing the device function FDA may assess the non-device function’s impact on that function’s safety and effectiveness.

On August 27, 2026, FDA and the Duke-Margolis Institute for Health Policy will host a free virtual public workshop on statistical considerations for digitally derived endpoints in clinical trials for drug and biological products, including updates on FDA efforts under PDUFA VII. Registration is through Duke-Margolis.

Subject matter experts at Hyman, Phelps & McNamara, P.C. are available to evaluate whether a given DHT is a device and to position a DHT program for both the grant and the eventual submission.