Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff

Issue Date: January 23, 2026
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, Cardiovascular
Status: Draft

Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff

This draft guidance document provides the FDA’s recommendations on clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of cuffless non-invasive blood pressure measuring device submissions.

Download the Guidance Document