Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ Draft guidance document on Q-Submission Program for medical device submissions, covering administrative/procedural and premarket topics.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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on March 14, 2024 Other (Public Domain) 0 reuses 0 favorites
The EMDN update From Ministry of Health (Italy) (MDS) ๐ฎ๐น The European Medical Device Nomenclature (EMDN) will be reviewed annually and updated based on the real world and feedback expressed by stakeholders. MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature describes the procedure for the annual review of the Europeanโฆ 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 February 29, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance for the Q-Submission Program, providing information on feedback and meetings for medical device submissions. 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
Inspection and audit feedback forms From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find further information about inspection and audit feedback forms. On this page they are available in pdf and Microsoft Word formats to download. 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 February 1, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Webinar presentation: Remote GMP inspections: Current feedback and future considerations From Therapeutic Goods Administration (TGA) ๐ฆ๐บ A webinar presentation discussing remote GMP inspections, including current feedback and future considerations. Focuses on manufacturing. 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 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations From European Medicines Agency (EMA) ๐ช๐บ Webinar to aid implementation of Medical Devices Regulation on drug-device combinations for multiple stakeholders. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed 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, 2021 Other (Public Domain) 0 reuses 0 favorites
Requesting FDA Feedback on Combination Products : Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance for requesting FDA feedback on combination products, focusing on over-the-counter products. 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 January 20, 2021 Other (Public Domain) 0 reuses 0 favorites
Submissions received: Scope of regulated software based medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Report on feedback to recent public consultation on the scope of regulated software products Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on August 17, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Nonbinding Feedback After Certain FDA Inspections of Device Establishments: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance for industry and FDA staff on nonbinding feedback after certain FDA inspections of device establishments. 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 April 21, 2020 Other (Public Domain) 0 reuses 0 favorites
Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2016-12333. The Food and Drug Administration (FDA) is issuing a final order to reclassify external cardiac compressors (ECC) (under FDA product code DRM), a preamendments class III device, into class II (special controls). FDA is also creating a separate classification regulationโฆ 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 May 25, 2016 Other (Public Domain) 0 reuses 0 favorites
Notice on the cardiovascular automatic feedback control drug delivery therapeutic instrument and other products categorized defined From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2007-10030 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on June 1, 2007 Other (Public Domain) 0 reuses 0 favorites