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 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
Medical devices and IVDs From Therapeutic Goods Administration (TGA) π¦πΊ Medical devices include a wide range of products such as bandages, syringes, in vitro diagnostic medical devices, surgical lasers, pacemakers and dialysis equipment. 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 May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser Notice No. 50) From Food and Drug Administration (FDA) πΊπΈ Guidance document on laser products' compliance with IEC standards for postmarket regulations. (150 characters) 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 October 3, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 884 Obstetrical and Gynecological 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 884 Obstetrical and Gynecological 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on the conformance of laser products with international standards 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on February 21, 2023 Other (Public Domain) 0 reuses 0 favorites
Compliance Guide for Laser Products (FDA 86-8260) From Food and Drug Administration (FDA) πΊπΈ A compliance guide for laser products, providing guidance on FDA regulations. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on February 21, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 874 Ear, Nose, and Throat 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 874 Ear, Nose, and Throat 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 January 9, 2023 Other (Public Domain) 0 reuses 0 favorites
Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a draft guidance for industry and FDA staff on labeling recommendations for LASIK lasers used in patient treatment. 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 October 7, 2022 Other (Public Domain) 0 reuses 0 favorites
Identification Labels for Certain Class I Laser Products (Laser Notice 48) From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on identification labels for certain Class I laser products, as outlined in Laser Notice 48. 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 27, 2021 Other (Public Domain) 0 reuses 0 favorites
All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46) From Food and Drug Administration (FDA) πΊπΈ This document is an industry letter titled "All Holders of Approved Variances For Laser Light Shows and Displays (Laser Notice 46)". 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 27, 2021 Other (Public Domain) 0 reuses 0 favorites
User Instruction Hazard Warnings (Laser Notice 35) From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "User Instruction Hazard Warnings (Laser Notice 35)" provides instructions and warnings for laser usage. 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 January 26, 2021 Other (Public Domain) 0 reuses 0 favorites
Lasers Manufactured and Used In-House (Laser Notice 14) From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Lasers Manufactured and Used In-House (Laser Notice 14)" provides information on laser manufacturing and usage. 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 January 26, 2021 Other (Public Domain) 0 reuses 0 favorites
Investigational Medical Laser Significant Risk Device (Laser Notice 31) From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Investigational Medical Laser Significant Risk Device (Laser Notice 31)". 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 January 26, 2021 Other (Public Domain) 0 reuses 0 favorites
Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; (Laser Notice 51) From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on the responsibilities of laser light show projector manufacturers, dealers, and distributors. 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 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55) From Food and Drug Administration (FDA) πΊπΈ A guidance document titled "Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)". 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 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Minimizing Risk for Children's Toy Laser Products: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Guidance document on minimizing risk for children's toy laser products, 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) From Food and Drug Administration (FDA) πΊπΈ Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) - A guidance document providing information on labeling options for laser 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 March 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDA From Food and Drug Administration (FDA) πΊπΈ A guidance document providing information on the exemption of Department of Defense from FDA performance standard for laser 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 March 19, 2020 Other (Public Domain) 0 reuses 0 favorites