Medical Device Federal Register

Federal Register :: Suggested Search - Medical Devices

https://www.federalregister.gov/medical-devices

In the U.S. medical devices are defined as a medical machine, contrivance, implant, in vitro reagent, or other similar or related article. The Food and Drug Administration is …

Federal Register :: Medical Devices; Neurological …

https://www.federalregister.gov/documents/2023/01/13/2023-00497/medical-devices-neurological-devices-classification-of-the-digital-therapy-device-to-reduce-sleep

Federal Register :: Medical Devices; Cardiovascular …

https://www.federalregister.gov/documents/2023/01/31/2023-01967/medical-devices-cardiovascular-devices-classification-of-the-software-for-optical-camera-based

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513 (f) (2) of the FD&C Act. Section 207 of …

Federal Register :: Medical Devices; Hematology and …

https://www.federalregister.gov/documents/2023/02/02/2023-02141/medical-devices-hematology-and-pathology-devices-classification-of-the-software-algorithm-device-to

Federal Register :: Medical Devices; Hematology and Pathology Devices; Classification of the Software Algorithm Device To Assist Users in Digital Pathology Rule …

Federal Register :: Medical Devices; Orthopedic …

https://www.federalregister.gov/documents/2023/01/05/2022-28601/medical-devices-orthopedic-devices-classification-of-the-bone-indentation-device

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513 (f) (2) of the FD&C Act. Section 207 of …

Device Registration and Listing | FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing

Device Registration and Listing | FDA Device Registration and Listing Owners or operators of establishments that are involved in the production and distribution of …

Federal Register :: Medical Devices; Orthopedic …

https://www.federalregister.gov/documents/2022/12/29/2022-28166/medical-devices-orthopedic-devices-classification-of-the-resorbable-implant-for-anterior-cruciate

Federal Register :: Medical Devices; Orthopedic Devices; Classification of the Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair Rule Medical …

Federal Register :: Medical Devices; Ophthalmic …

https://www.federalregister.gov/documents/2023/01/20/2023-01049/medical-devices-ophthalmic-devices-classification-of-the-intense-pulsed-light-device-for-managing

Federal Register :: Medical Devices; Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye Rule Medical Devices; …

Federal Register :: Medical Devices; Gastroenterology …

https://www.federalregister.gov/documents/2023/01/20/2023-01048/medical-devices-gastroenterology-urology-devices-classification-of-the-computerized-behavioral

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513 (f) (2) of the FD&C Act. Section 207 of …

Federal Register Documents | FDA

https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents

Aug 11, 2022