Endosseous Dental Implants and Endosseous Dental Implant Abutments - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document outlining performance criteria for safety and performance of endosseous dental implants and abutments, aimed at industry and FDA staff in the premarket phase. 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 1 month ago Other (Public Domain) 0 reuses 0 favorites
Dental Impression Materials - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document outlining performance criteria for safety and performance of dental impression materials in the premarket phase, for FDA staff and industry. 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 September 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Ceramics - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document outlining performance criteria for safety and performance of dental ceramics in the premarket phase, aimed at 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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Cements - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document outlining performance criteria for safety and performance of dental cements, aimed at industry and FDA staff involved in premarket processes. 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 September 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Air Powered Dental Handpieces and Air Motors - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document outlining performance criteria for safety and performance of air-powered dental handpieces and air motors, aimed at industry and FDA staff in premarket phase. 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 September 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - FDA-2019-D-0359 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 July 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Terms of Reference: Access Consortium From Therapeutic Goods Administration (TGA) 🇦🇺 The Access Consortium Terms of Reference have been updated to include better defined membership criteria and international collaborative mechanisms. 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 March 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Performance assessment according to IVDR From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document outlining the process and criteria for evaluating performance in compliance with the In Vitro Diagnostic Regulation (IVDR). 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 November 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Priority determination eligibility criteria From Therapeutic Goods Administration (TGA) 🇦🇺 Update to currency of data required for criteria assessment 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 July 26, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Ordinance - PRT No. 511 of 30/09/2021 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Defines the chronological criteria for analysis or approval of registration or notification processes for products defined as medical devices, within the scope of the National Health Surveillance Agency. 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 July 12, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices: Post-Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form From International Medical Device Regulators Forum (IMDRF) 🌍 (Reclassified from Technical) Information document: IMDRF/NCAR WG/N14 FINAL:2023 (Edition 4) Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on April 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff". It falls under the topic of "Premarket". 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 27, 2023 Other (Public Domain) 0 reuses 0 favorites
Different versions and review criteria of CND From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - The different versions and review criteria of the CND 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 January 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices (Text with EEA relevance) From European Parliament 🇪🇺 Commission Implementing Regulation (EU) 2022/944 lays down rules for the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices. 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 June 17, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) /... laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices From European Parliament 🇪🇺 This document is an implementing regulation that establishes rules for EU reference laboratories in the field of in vitro diagnostic medical devices. 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 June 17, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 687 of 13/05/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the criteria for granting or renewing the Good Manufacturing Practice Certification for Medical Devices. 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 May 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway" for premarket review. 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 12, 2022 Other (Public Domain) 0 reuses 0 favorites
Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry and FDA staff on safety and performance criteria for denture base resins. 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 12, 2022 Other (Public Domain) 0 reuses 0 favorites
Surgical Sutures - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for the FDA and industry staff on the safety and performance criteria for surgical sutures in the premarket phase. 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 8, 2022 Other (Public Domain) 0 reuses 0 favorites
Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document titled "Orthopedic Fracture Fixation Plates - Performance Criteria for Safety and Performance Based Pathway" for premarket review. 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 8, 2022 Other (Public Domain) 0 reuses 0 favorites
