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
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on early collaboration meetings under the FDA Modernization Act, focusing on IDE 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 August 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on changes or modifications during clinical investigations for Investigational Device Exemption (IDE) 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 August 10, 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
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
Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1) From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for CDRH staff on determining the intended use for 510(k) devices in the premarket stage. 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 March 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on interactive procedures for day-100 meetings and subsequent deficiencies for CDRH and industry. 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 March 18, 2020 Other (Public Domain) 0 reuses 0 favorites
1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "1-Consolidated Annual Report for a Device product line (1-CARD) - Guidance for Industry and CDRH Reviewers". 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 March 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on the procedures for obtaining Class II device exemptions from premarket notification. 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 February 28, 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