21 CFR Chapter I Subchapter H – Medical Devices – Part 800 General From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 800 General: A regulation governing medical devices. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 892 Radiology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 892 Radiology Devices". Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on June 7, 2023 Other (Public Domain) 0 reuses 0 favorites
Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Center for Devices and Radiological Health (CDRH) Appeals Processes" that provides information about 517A and is relevant to administrative/procedural and premarket topics. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on the appeals processes of the Center for Devices and Radiological Health (CDRH) for industry and FDA staff. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on May 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions". It focuses on premarket topics and is intended for industry and FDA staff. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 15, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Technical Amendments From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-06354. The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations. These revisions are necessary to reflect changes to the Agency's Center for Devices and Radiological Health's organizational structure, including the reorganization of… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-00497. The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are identified in this order… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 22, 2020 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-00496. The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software 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… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 22, 2020 Other (Public Domain) 0 reuses 0 favorites
Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-14096. The Food and Drug Administration (FDA or Agency) is issuing a final rule to amend its regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH or the Center) under… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 2, 2019 Other (Public Domain) 0 reuses 0 favorites
Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-00646. The Food and Drug Administration (FDA) is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 17, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Device Classification Procedures; Change of Address; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-17564. The Food and Drug Administration (FDA or Agency) is amending the Medical Device Classification Procedures regulation to reflect a change in address for the Center for Devices and Radiological Health (CDRH). This action is editorial in nature and is intended to improve… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 21, 2017 Other (Public Domain) 0 reuses 0 favorites