Competence, Training, and Conduct Requirements for Regulatory Reviewers From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/GRRP WG/N40 FINAL:2024 (Edition 2) 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5 From Food and Drug Administration (FDA) 🇺🇸 A guidance document titled "Reviewers Guidance Checklist For Orthopedic External Fixation Devices Version #5" for premarket assessment. 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
Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA reviewers on Investigational Device Exemptions for organ transplantation solutions. 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 Section 216 of the Food and Drug Administration Modernization Act of 1997 - Guidance for Industry and for FDA Reviewers From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA reviewers on Section 216 of the FDA Modernization Act of 1997. 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
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA reviewers on the content and format of premarket notification submissions for liquid chemical sterilants/high level disinfectants. 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
Aqueous Shunts - 510(k) Submissions - Guidance for Industry and for FDA Reviewers/Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for FDA reviewers and staff on 510(k) submissions for aqueous shunts, focusing on 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 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
Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for premarket reviewers on nebulizers, metered dose inhalers, spacers, and actuators. 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 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance Document for Premarket Notification Submissions for Nitric Oxide Delivery Apparatus, Nitric Oxide Analyzer and Nitrogen Dioxide Analyzer: Guidance for Industry and for FDA Reviewers From Food and Drug Administration (FDA) 🇺🇸 A guidance document for premarket notification submissions for nitric oxide delivery apparatus, nitric oxide analyzer, and nitrogen dioxide analyzer. 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
Clinical Chemistry and Clinical Toxicology Devices; Classification of B-Type Natriuretic Peptide Test System From Food and Drug Administration (FDA) 🇺🇸 Document number 01-4847. The Food and Drug Administration (FDA) is classifying the B- type natriuretic peptide (BNP) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Control Guidance Document for… 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 28, 2001 Other (Public Domain) 0 reuses 0 favorites
Immunology and Microbiology Devices; Classification of Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test Systems From Food and Drug Administration (FDA) 🇺🇸 Document number 00-29841. The Food and Drug Administration (FDA) is classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Guidance for Industry… 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 22, 2000 Other (Public Domain) 0 reuses 0 favorites
Obstetrical and Gynecological Devices; Classification of the Clitoral Engorgement Device From Food and Drug Administration (FDA) 🇺🇸 Document number 00-19489. The Food and Drug Administration (FDA) is classifying the clitoral engorgement device into class II (special controls). The special control that will apply is a guidance document entitled: "Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance… 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 2, 2000 Other (Public Domain) 0 reuses 0 favorites