21 CFR Chapter I Subchapter H – Medical Devices – Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) 🇺🇸 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 – Medical Devices – Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – 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
Requesting a waiver for a medical device without CE marking From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Requesting a waiver for a medical device without CE marking 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 August 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Authorization for clinical investigation of class IIa or IIb invasive or class III medical devices not bearing CE marking for intended use 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 August 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,… 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 5, 2024 Creative Commons Attribution 3.0 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
21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Draft guidance on how to interpret ‘significant change’ of a medical device: Overview From Health Canada 🇨🇦 This guidance document has been updated to expand on the definition of “significant change” in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. 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 7, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-26209. The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings; wound dressings… 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 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Custom-made implantable Class III devices From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 The document discusses the development and use of custom-made implantable Class III medical devices. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on clinical evidence requirements for medical devices: Overview From Health Canada 🇨🇦 This document provides guidance to manufacturers of Class III and IV medical devices and regulatory representatives on the clinical evidence requirements for 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 April 17, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-06566. The Food and Drug Administration (FDA or Agency) is issuing a final rule to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately requiring the filing of a 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 March 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-06565. The Food and Drug Administration (FDA or Agency) is issuing a final order to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, an unclassified, preamendments device following the classification… 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 March 30, 2023 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-23868. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to… 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-13954. The Food and Drug Administration (FDA, Agency, or we) is proposing on its own initiative to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are postamendments class III devices (product codes OYD and… 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 30, 2022 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-10461. The Food and Drug Administration (FDA, we, or the Agency) is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class… 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 16, 2022 Other (Public Domain) 0 reuses 0 favorites
De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for the industry and FDA staff on the De Novo classification process for automatic Class III designation evaluation. 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 18, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-27137. The Food and Drug Administration (FDA or Agency) is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a 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 December 15, 2021 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25372. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, a postamendments class III device with the product code MZF, into class II (special controls), subject to 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 24, 2021 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2021-25379. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class… 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 22, 2021 Other (Public Domain) 0 reuses 0 favorites