Medical Devices; Cardiovascular Devices; Classification of the Electrocardiograph Software for Over-the-Counter Use
fda-device · Food and Drug Administration · Rule · Published 2022-01-18 · Effective 2022-01-18 · 87 FR 2547
Document
Document number
2022-00827
Federal Register citation
87 FR 2547
CFR reference
21 CFR 870
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-01-18
Effective date
2022-01-18
HHS docket
Docket No. FDA-2021-N-0914
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the electrocardiograph software for over-the-counter use 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 electrocardiograph software for over-the- counter use's 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.