federal_register: 2022-08731
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08731 | Medical Devices; General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use | Rule | The Food and Drug Administration (FDA or we) is classifying the autofluorescence detection device for general surgery and dermatological 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 autofluorescence detection device for general surgery and dermatological 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. | 2022-04-25 | 2022 | 4 | https://www.federalregister.gov/documents/2022/04/25/2022-08731/medical-devices-general-and-plastic-surgery-devices-classification-of-the-autofluorescence-detection | https://www.govinfo.gov/content/pkg/FR-2022-04-25/pdf/2022-08731.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or we) is classifying the autofluorescence detection device for general surgery and dermatological use into class II (special controls). The special controls that apply to the device type are identified in this... |