# Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document Source: https://www.globalkeysolutions.net/guidances/guidance-document/cuffless-non-invasive-blood-pressure-measuring-devices-clinical-performance-testing-and-evaluation-draft-guidance-for-industry-and-food-and-drug-administration-staff/13ff4501-ce59-4262-a18d-8d3e79ad570a > FDA guidance document: Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff.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. Get complete insights and analysis. --- ## Details - Title: Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff - Communication Type: Guidance Document - Product Type: devices - Office Name: Center for Devices and Radiological Health - Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7 - Issue Date: 2026-01-23 - Comment Close Date: 2026-03-24 - Last Changed: 2026-01-22 - Docket Number: FDA-2025-D-0851 ## Related Documents - [Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/characterization-of-metallic-coatings-andor-calcium-phosphate-coatings-on-orthopedic-devices-draft-guidance-for-industry-and-food-and-drug-administration-staff/75d15d0b-10b7-4f21-8395-0018919f5abb) - [Pulse Oximeters for Medical Purposes - Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/pulse-oximeters-for-medical-purposes-non-clinical-and-clinical-performance-testing-labeling-and-premarket-submission-recommendations-draft-guidance-for-industry-and-food-and-drug-administration-staff/0501096b-4fc1-492b-9162-43d891128680) - [Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions: Draft Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/recommendations-for-the-use-of-clinical-data-in-premarket-notification-510k-submissions-draft-guidance-for-industry-and-food-and-drug-administration-staff/b928b357-83ae-4836-9aad-28ebb7169cc6)