Medical Devices; Cardiovascular Devices; Classification of the Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
fda-device · Food and Drug Administration · Rule · Published 2023-01-31 · Effective 2023-01-31 · 88 FR 6166
Document
Document number
2023-01967
Federal Register citation
88 FR 6166
CFR reference
21 CFR 870
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2023-01-31
Effective date
2023-01-31
HHS docket
Docket No. FDA-2023-N-0091
Abstract
The Food and Drug Administration (FDA, Agency, or we) is classifying the software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate 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 software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate'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.