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FDA unveils TEMPO pilot to let some digital health devices enter CMS 'Access' with enhanced data collection
Summary
FDA announced TEMPO, a pilot offering enforcement discretion for certain digital health devices used inside CMS's Access model; manufacturers can request permission to collect real‑world performance data in a controlled setting and must secure enhanced beneficiary consent, officials said.
Jim Traficant, chief of staff at the Food and Drug Administration, announced TEMPO (Technology Enabled Meaningful Patient Outcomes), a pilot to let certain digital health device manufacturers request FDA enforcement discretion to make devices available in CMS's Access model while collecting agreed real‑world data.
Under TEMPO, devices that would typically require FDA premarket authorization may be used inside Access if FDA determines enforcement discretion is appropriate and the manufacturer and FDA agree on data collection and patient‑risk mitigation plans. Traficant said TEMPO "is a regulatory sandbox to facilitate digital health technologies that improve health outcomes."
Participant safeguards: Devices used under TEMPO will require enhanced consent for enrolled beneficiaries informing them of FDA pilot participation and the types of data shared with FDA. Additional data collection beyond Access's standard reporting may be negotiated and shared with FDA as agreed.
Process and timing: Traficant said manufacturers should apply directly to FDA when the TEMPO application process opens; a Federal Register notice with additional participation details is expected early next year.
Why it matters: FDA framed TEMPO as a bridge between device development and reimbursement, enabling controlled use of promising digital health technologies while generating performance data that could support future marketing authorizations.
Ending: The pilot is optional and intended for devices that would otherwise require premarket authorization; organizers said TEMPO aims to speed access to breakthrough digital therapies while collecting real‑world evidence to inform regulatory decisions.
