Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses From Food and Drug Administration (FDA) 🇺🇸 A guidance document providing instructions for submitting a color additive petition for contact lenses to the Center for Food Safety and Applied Nutrition. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices From Food and Drug Administration (FDA) 🇺🇸 This document provides FDA recommendations for submitting chemical and technological data on color additives for food, drugs, cosmetics, or medical devices. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document outlining the electronic submission template for medical device De Novo requests, aimed at industry and FDA staff. Focus on electronic submissions 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 1 month ago Other (Public Domain) 0 reuses 0 favorites
Chapter 1.1 - submission type guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Northern Ireland. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 1 - submission type guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document titled "Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product". It focuses on combination 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on premarket notification submissions for metal expandable biliary stents. 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) 🇪🇺 Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. 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 21, 2024 Other (Public Domain) 0 reuses 0 favorites
National Register of Breast Prosthetic Implants - Appointment of data submission manager for distributors From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 25, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/BWP/187338/2014 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on process validation for finished products - information and data to be provided in regulatory submissions From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental curing lights. 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 July 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A draft guidance document for industry and FDA staff on premarket notification (510(k)) submissions for dental composite resin devices. 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 July 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Authorised Prescriber: online system From Therapeutic Goods Administration (TGA) 🇦🇺 The Special Access Scheme (SAS) & Authorised Prescriber (AP) Online System (SAS & AP online system) is the preferred method of submission for AP applications. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC) From International Medical Device Regulators Forum (IMDRF) 🌍 IMDRF/RPS WG/N9 Final:2024 (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 June 25, 2024 Other (Public Domain) 0 reuses 0 favorites
In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (IVD ToC) From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/RPS WG/N13 FINAL:2024 (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 June 25, 2024 Other (Public Domain) 0 reuses 0 favorites
Submissions received: Regulation of software, including Software as a Medical Device (SaMD) From Therapeutic Goods Administration (TGA) 🇦🇺 Submissions received: Regulation of software, including Software as a Medical Device (SaMD) 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed refinements to the regulation of personalised medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed refinements to the regulation of personalised 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed reclassification of spinal implantable medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Proposed reclassification of spinal implantable 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites