FDA Drops Guide for Testing Wrist-Worn Blood Pressure Gadgets
Published Date: 1/23/2026
Notice
Summary
The FDA just dropped a draft guide for companies making cuffless blood pressure devices, showing how to test and prove their gadgets work well. This affects device makers aiming to get FDA approval and helps make sure your new tech is safe and accurate. Comments on this draft are open until March 24, 2026, so get your thoughts in before then!
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Draft testing guidance for cuffless BP devices
The FDA released a draft guidance titled "Cuffless Non-invasive Blood Pressure Measuring Devices--Clinical Performance Testing and Evaluation" that gives recommendations for clinical performance testing and evaluation to support premarket submissions for cuffless blood pressure measuring devices. The draft is not final and is not for implementation at this time.
Comment opportunity and deadline
Stakeholders may submit electronic or written comments on the draft guidance; comments must be submitted by March 24, 2026 for the Agency to consider them before it begins work on the final guidance. The docket number for comments is FDA-2025-D-0851 and submissions go through Regulations.gov or by mail to the Dockets Management Staff.
No new paperwork collection required
The draft guidance states it contains no new collection of information under the Paperwork Reduction Act and instead refers to previously approved FDA collections with OMB control numbers 0910-0120, 0910-0844, 0910-0756, and 0910-0485. These existing approvals cover premarket notification, De Novo classification, Q-submissions, and medical device labeling/UDI respectively.
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