Published on: 2021-07860. Final rule. 2021-07860. Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
Published on: 2020-00497. Final amendment; final order. 2020-00497. Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer
Published on: 2020-00496. Final amendment; final order. 2020-00496. Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software
Published on: 2019-27394. Final amendment; final order. 2019-27394. Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices