Chemical Analysis for Biocompatibility Assessment of Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A draft guidance document by the FDA and industry on chemical analysis for assessing biocompatibility of medical devices, covering CMC and premarket topics. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency 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 today Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on Immunology and Microbiology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 866. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 88.88888888888889/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 days ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 886 Ophthalmic Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 886 Ophthalmic Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 872 Dental Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 872 Dental Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) πΊπΈ A regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 870 Cardiovascular Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 890 Physical Medicine Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on physical medicine devices under 21 CFR Chapter I Subchapter H - Medical Devices - Part 890. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 888 Orthopedic Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 888 Orthopedic Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 882 Neurological Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 882 Neurological Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated 2 weeks 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
21 CFR Chapter I Subchapter H β Medical Devices β Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) πΊπΈ 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on August 19, 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
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
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ Draft guidance document by the FDA on the regulation of complementary and alternative medicine products, covering administrative 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 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
Dental Curing Lights - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ 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) πΊπΈ 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
21 CFR Chapter I Subchapter H β Medical Devices β Part 878 General and Plastic Surgery Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 878 General and Plastic Surgery Devices". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
SFDA Recognized Standards (Supporting Medical Device Premarket Submissions) From Saudi Food and Drug Authority (SFDA) πΈπ¦ This document provides guidance on SFDA recognized standards for medical device premarket submissions. 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 May 21, 2024 Other (Public Domain) 0 reuses 0 favorites