federal_register: 2023-00010
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023-00010 | Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate | Rule | The Food and Drug Administration (FDA, Agency, or we) is classifying the hardware and 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 hardware and 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. | 2023-01-06 | 2023 | 1 | https://www.federalregister.gov/documents/2023/01/06/2023-00010/medical-devices-cardiovascular-devices-classification-of-the-hardware-and-software-for-optical | https://www.govinfo.gov/content/pkg/FR-2023-01-06/pdf/2023-00010.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency, or we) is classifying the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special... |