Mpox Diagnostic Tests From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number MD01-2023/24 - Version 1 Metadata quality: Metadata quality: Data description empty 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: 44.44444444444444/100 Updated 1 week ago Other (Public Domain) 0 reuses 0 favorites
Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Draft Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties From Food and Drug Administration (FDA) πΊπΈ A draft guidance document by the FDA for industry, staff, and interested parties on incorporating voluntary patient preference information throughout a product's life cycle. 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 week ago Other (Public Domain) 0 reuses 0 favorites
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) πΊπΈ 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) πΊπΈ 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
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on the use of ISO 10993-1 for evaluating and testing medical devices within a risk management process. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Direct Final Rule Procedures: Guidance for FDA and Industry From Food and Drug Administration (FDA) πΊπΈ Guidance document providing procedures for FDA and industry regarding direct final rule implementation. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document providing questions and answers on conducting remote regulatory assessments for various topics including adverse event reporting, compliance, and pharmaceutical quality. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document outlining the Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers, providing guidance 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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 3 weeks ago Other (Public Domain) 0 reuses 0 favorites
Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document for small entities on complying with amendments to the Mammography Quality Standards Act and Regulations, 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 1 month 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) πΊπΈ 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
Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document for industry and FDA staff on predetermined change control plans for medical devices 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
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on FDA and industry procedures for Section 513(g) requests under the Federal Food, Drug, and Cosmetic Act. 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 month ago Other (Public Domain) 0 reuses 0 favorites
Acceptable Media for Electronic Product User Manuals: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document outlining acceptable media formats for electronic product user manuals, aimed at industry professionals 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 1 month ago Other (Public Domain) 0 reuses 0 favorites
Using Electronic Means to Distribute Certain Product Information: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Guidance for Industry on using electronic means to distribute certain product information, focusing on administrative and procedural 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Labs, 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 August 9, 2024 Other (Public Domain) 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) πΊπΈ 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
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for manufacturers of in vitro diagnostic devices on Clinical Laboratory Improvement Amendments (CLIA) waiver applications. 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
Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA staff on non-clinical engineering tests and labeling for intravascular stents and delivery systems. 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) πΊπΈ 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
Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4: Draft Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for industry and FDA staff on using glass syringes for delivering drug and biological 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