Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current release: IMDRF/AE WG/N43FINAL:2024 Updated Annexes 20 April 2024; Annex A_1 – updated 9 May 2024 (refer release notes for details) 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 7, 2024 Other (Public Domain) 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
Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons and Drug-Eluting Stents to the MHRA From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The findings and recommendations of the Expert Advisory Group on paclitaxel drug-coated balloon catheters and drug-eluting stents which are used to treat patients with peripheral arterial disease. 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, 2021 Open Government Licence 2.0 (United Kingdom) 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
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-32592. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the electroconvulsive therapy (ECT) device for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD)… 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 29, 2015 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
Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-00027. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify nonroller-type cardiopulmonary bypass blood pump devices, when used for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special… 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 7, 2014 Other (Public Domain) 0 reuses 0 favorites
Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-14553. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify intra-aortic balloon and control system devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a… 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 19, 2013 Other (Public Domain) 0 reuses 0 favorites
Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-12122. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options 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 May 21, 2013 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