Federal Register #FDA-2026-N-9907

FDA Classifies Cardiovascular Machine Learning-Based Notification Software as Class II Medical Device

This FDA notice announces the classification of cardiovascular machine learning-based notification software as a Class II medical device with special controls. - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health - OEMs and Vendors: - Viz.ai, Inc. (submitted De Novo classification request for Viz HCM device) - Products/Services Requested: - Cardiovascular machine learning-based notification software - Part number: 870.2380 - No specific purchase quantities or procurement requested - Unique or Notable Requirements: - Device uses machine learning to suggest likelihood of cardiovascular disease for further referral or diagnostic follow-up - Not intended for diagnostic quality output or arrhythmia detection - Special controls include clinical performance testing, software verification and validation, human factors assessment, and specific labeling requirements - Classification aims to ensure safety and effectiveness, reduce regulatory burdens, and enhance patient access to innovative devices - Premarket notification required under section 510(k) - No procurement or purchase activity is requested in this notice

Description

The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). This software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up based on non-invasive physiological inputs. The classification aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens. The device is intended as a basis for further testing and is not meant to provide diagnostic quality output or detect arrhythmias.

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