CDRH Clinical Study Service Contract

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health is soliciting commercial clinical study services under solicitation number 75F40126Q00193, with proposals due by August 4, 2026. The contract is a Firm Fixed Price (FFP) award for remote performance of a clinical study involving the collection, annotation, and delivery of 12-lead ECG data from 150 subjects in the base year and 35 subjects per optional year, alongside the development of a synthetic retrospective dataset of at least 4,000 subjects to support the validation of an FDA-developed ECG signal transformation framework for AI/ML-enabled cardiovascular devices. Performance is scheduled to begin September 30, 2026, with up to four one-year optional extensions through September 29, 2031. All deliverables, including approved study protocols, de-identified datasets, monthly progress reports, and a final public-ready dataset, must comply with FDA and IRB requirements, HIPAA standards for de-identification, and FDA-approved data collection procedures. The contract requires continuous monitoring of signal quality, synchronization of FDA-approved ECG devices, and collection of comprehensive metadata during resting, supine conditions. Offerors must demonstrate extensive experience in AI and machine learning applications for 10 or more years, a proven history analyzing wearable datasets, affiliation with a hospital within 10 miles of Silver Spring, Maryland, and a track record of conducting at least five clinical studies involving both healthy and unhealthy subjects, including publications in prestigious journals. Proposals must be submitted electronically via email to Natalie.Brown@fda.hhs.gov by the deadline, formatted into two volumes: a Technical Approach detailing methodology and personnel resumes, and a Price volume using the provided attached Price Sheet, which currently contains no populated values. All offerors must have an active UEI in SAM.gov, maintain compliance with employment eligibility, anti-trafficking, and cybersecurity regulations, and adhere to clauses covering whistleblower protections, subcontractor exclusions, paid sick leave, and data safeguarding. Payment must be processed exclusively through the U.S. Treasury’s Invoice Processing Platform, with no physical delivery or FOB terms applicable. The government will evaluate proposals based on technical merit and overall advantage, not solely on price, and will select the offeror best positioned to deliver high-quality, compliant clinical data under strict oversight. Security clearances are not required, but robust data protection measures