Banned Devices; Proposal To Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-06037. The Food and Drug Administration (FDA, the Agency, or we) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). FDA has determined these devices present an unreasonable and substantial risk of… 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 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Notification of substantial changes to performance studies 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 March 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Substantial modification of performance study under Regulation (EU) 2017/746 From European Commission 🇪🇺 This document discusses the significant changes made to performance studies for In Vitro Diagnostic medical devices (IVD) under Regulation (EU) 2017/746. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Notification of substantial modification of a clinical investigation of a medical device From Health Products Regulatory Authority (HPRA) 🇮🇪 A form detailing substantial modifications to a clinical investigation of a medical device. 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 on June 8, 2022 Other (Public Domain) 0 reuses 0 favorites
Substantial modification of clinical investigation under Medical Device Regulation From European Commission 🇪🇺 Learn about the significant changes in clinical investigation under the Medical Device Regulation. 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 on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Changes affecting TGA-issued conformity assessment certificates From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for notifying the TGA about ‘substantial changes’ to, or transfers of, conformity assessment certificates. 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 August 19, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Multi-stakeholder webinar to support implementation of the Medical Devices Regulation on drug-device combinations From European Medicines Agency (EMA) 🇪🇺 Webinar to aid implementation of Medical Devices Regulation on drug-device combinations for multiple stakeholders. Metadata quality: Metadata quality: Data description filled Files documented 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: 66.66666666666666/100 Updated on January 22, 2021 Other (Public Domain) 0 reuses 0 favorites
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on considering benefit-risk factors for determining substantial equivalence in premarket notifications with different technological characteristics. 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 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-04328. The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self- injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury… 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 6, 2020 Other (Public Domain) 0 reuses 0 favorites
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and FDA Staff." A guidance document on evaluating substantial equivalence in premarket notifications. 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 28, 2019 Other (Public Domain) 0 reuses 0 favorites
Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-30382. The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that 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 December 19, 2016 Other (Public Domain) 0 reuses 0 favorites
Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-09433. The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or self- injurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be… 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 25, 2016 Other (Public Domain) 0 reuses 0 favorites
Banned Devices; Proposal To Ban Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-06360. The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that 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 March 22, 2016 Other (Public Domain) 0 reuses 0 favorites
Performance studies of in vitro diagnostic medical devices From Federal Institute for Drugs and Medical Devices (BfArM) 🇩🇪 Decision tree performance studies IVDR / MPDG Request for authorisation Notification of a Post-Market Performance Study in accordance with Article 70(1) of Regulation (EU) 2017/746 (IVDR)Notification of a Post-Market Performance Study Notifications of performance studies involving companion… 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 December 28, 2023 Other (Public Domain) 0 reuses 0 favorites
Clinical investigations according to MDR / MPDG From Federal Institute for Drugs and Medical Devices (BfArM) 🇩🇪 Decision tree clinical investigations MDR / MPDG Request for authorisation Notification of a Post-Market Clinical Follow-up investigation in accordance with Article 74(1) of Regulation (EU) 2017/745 (MDR)Notification of a PMCF investigation Notification of Other Clinical Investigations according… 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 November 26, 2023 Other (Public Domain) 0 reuses 0 favorites