21 CFR Chapter I Subchapter H – Medical Devices – Part 886 Ophthalmic Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – 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
Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-19882. The Food and Drug Administration (FDA, Agency, or we) is classifying the hydrophilic re-coating solution into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the… 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-10895. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA is… 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 (Public Domain) 0 reuses 0 favorites
Medical devices: legal requirements for specific medical products From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic 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 July 1, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-01049. The Food and Drug Administration (FDA, Agency, or we) is classifying the intense pulsed light device for managing dry eye into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified… 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 January 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry on compliance with 21 CFR Part 4 for certain ophthalmic products, focusing 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 March 22, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Electromechanical Tear Stimulator From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-03540. The Food and Drug Administration (FDA or we) is classifying the electromechanical tear stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the… 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 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Retinal Diagnostic Software Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-01147. The Food and Drug Administration (FDA, Agency, or we) is classifying the retinal diagnostic software device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language 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 January 21, 2022 Other (Public Domain) 0 reuses 0 favorites
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices From Food and Drug Administration (FDA) 🇺🇸 This is a guidance document titled "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices" focused 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 4, 2019 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-22785. The Food and Drug Administration (FDA or we) is classifying the intranasal electrostimulation device for dry eye symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified… 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 October 19, 2018 Other (Public Domain) 0 reuses 0 favorites
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2018-20763. The Food and Drug Administration (FDA) is issuing this proposed order to reclassify the ultrasound cyclodestructive device, a postamendments class III device (regulated under product code LZR), into class II (special controls), subject to premarket notification. FDA is… 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 September 25, 2018 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2017-27280. The Food and Drug Administration (FDA or we) is classifying the tear electrostimulation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the tear… 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 December 19, 2017 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-22801. The Food and Drug Administration (FDA) is classifying the strabismus detection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the strabismus detection… 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 September 22, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-13788. The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the… 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 10, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-12683. The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the diurnal pattern… 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 31, 2016 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Oral Electronic Vision Aid From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-24026. The Food and Drug Administration (FDA) is classifying the oral electronic vision aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral electronic… 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 September 22, 2015 Other (Public Domain) 0 reuses 0 favorites
Circular of the General Office of the Food and Drug Administration on the Follow-up of Suspected Group Adverse Incident of Perfluoropropane Gas for Ophthalmic Use Produced by Tianjin Jingming New Technology Development Co. From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2015-10274 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 30, 2015 Other (Public Domain) 0 reuses 0 favorites
Notice of the General Office of the Food and Drug Administration on the Suspension of Sales and Use of Perfluoropropane Gas for Ophthalmic Use Produced by Tianjin Jingming New Technology Development Co. From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2015-10221 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 8, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-08940. The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid… 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 April 21, 2014 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-27365. The Food and Drug Administration (FDA or Agency) is classifying the scleral plug into class II (special controls), and exempting the scleral plugs composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from premarket… 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 15, 2013 Other (Public Domain) 0 reuses 0 favorites