federal_register: 2022-28173
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022-28173 | Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device | Rule | The Food and Drug Administration (FDA, Agency or we) is classifying the interventional cardiovascular implant simulation software device 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 interventional cardiovascular implant simulation software device'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. | 2022-12-28 | 2022 | 12 | https://www.federalregister.gov/documents/2022/12/28/2022-28173/medical-devices-cardiovascular-devices-classification-of-the-interventional-cardiovascular-implant | https://www.govinfo.gov/content/pkg/FR-2022-12-28/pdf/2022-28173.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA, Agency or we) is classifying the interventional cardiovascular implant simulation software device into class II (special controls). The special controls that apply to the device type are identified in this order... |