Medical Devices; Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals
fda-device · Food and Drug Administration · Rule · Published 2022-06-01 · Effective 2022-06-01 · 87 FR 32988
Document
Document number
2022-11699
Federal Register citation
87 FR 32988
CFR reference
21 CFR 870
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-06-01
Effective date
2022-06-01
HHS docket
Docket No. FDA-2022-N-0713
Abstract
The Food and Drug Administration (FDA or we) is classifying the coronary artery disease risk indicator using acoustic heart signals into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the coronary artery disease risk indicator using acoustic heart signals' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.