Medical device safety and use From Health Canada 🇨🇦 Medical device safety: From bandages to pacemakers, Health Canada ensures benefits outweigh risks, monitoring post-market use. 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 30, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Principle 6: Benefits of medical devices to outweigh any undesirable effects From Therapeutic Goods Administration (TGA) 🇦🇺 Principle 6: Benefits of medical devices to outweigh any undesirable effects 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Five questions to ask your health professional before you get a medical implant From Therapeutic Goods Administration (TGA) 🇦🇺 It's important that you discuss the risks and benefits of all options available to you with your health professional before making a decision. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval Applications for Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Cream, or Ointment; and Liquid Wound Washes Containing Medically Important Antimicrobials From Food and Drug Administration (FDA) 🇺🇸 Document number 2023-26208. The Food and Drug Administration (FDA, Agency, or we) is proposing to require the filing of a premarket approval application (PMA) for certain solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes containing… 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
Monitoring of healthcare equipment From Ministry of Health (Italy) (MDS) 🇮🇹 This document discusses the monitoring of healthcare equipment, focusing on its importance and benefits. 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 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-00501. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption… 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 13, 2022 Other (Public Domain) 0 reuses 0 favorites
Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-27045. The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications… 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 17, 2019 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Blood Lancets From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-04579. The Food and Drug Administration (FDA) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III. 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 March 3, 2016 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-09909. The Food and Drug Administration (FDA or the Agency) is issuing a proposed administrative order to require the filing of a premarket approval application (PMA) if the surgical mesh for transvaginal pelvic organ prolapse (POP) repair device is reclassified from class II… 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 1, 2014 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System. From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-06723. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments devices: Automated external defibrillators… 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 25, 2013 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-01006. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: Hip joint metal/metal semi-… 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 18, 2013 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Shortwave Diathermy for All Other Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-16487. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device, shortwave diathermy (SWD) for all other uses.… 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 6, 2012 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-16486. The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the cardiovascular permanent pacemaker electrode. The Agency has… 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 6, 2012 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-15244. The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for implantable pacemaker pulse generators. The Agency has summarized its… 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 22, 2012 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-15258. The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for pacemaker programmers. The Agency has summarized its findings regarding… 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 22, 2012 Other (Public Domain) 0 reuses 0 favorites
Gastroenterology-Urology Devices; Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-3810. The Food and Drug Administration (FDA) is proposing to reclassify the sorbent hemoperfusion system, a preamendments class III device, into class II (special controls) for the treatment of poisoning and drug overdose, and to require the filing of a premarket approval… 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 17, 2012 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-20664. The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following three class III preamendments devices: Ventricular bypass… 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 16, 2011 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-19957. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the Cranial Electrotherapy Stimulator. The Agency is also summarizing its proposed… 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 8, 2011 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-19959. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following class III preamendments device: Cardiovascular permanent pacemaker… 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 8, 2011 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-19733. The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device pacemaker programmers. The agency is also… 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 4, 2011 Other (Public Domain) 0 reuses 0 favorites