federal_register: 2018-22837
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2018-22837 | Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device | Rule | The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I 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, in part by reducing regulatory burdens. | 2018-10-19 | 2018 | 10 | https://www.federalregister.gov/documents/2018/10/19/2018-22837/medical-devices-general-and-plastic-surgery-devices-classification-of-the-wound-autofluorescence | https://www.govinfo.gov/content/pkg/FR-2018-10-19/pdf/2018-22837.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of... |