Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - FDA-2019-D-0359 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence From European Commission 🇪🇺 Document discusses DSVG 05 guidelines on Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence, focusing on Post-Market Surveillance and Vigilance (PMSV). 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 June 27, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 884 Obstetrical and Gynecological Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 884 Obstetrical and Gynecological 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 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA reviewers on Investigational Device Exemptions for organ transplantation solutions. 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 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Submissions received: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper 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 February 24, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on using animal studies to evaluate organ preservation devices in premarket stage. 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 May 7, 2019 Other (Public Domain) 0 reuses 0 favorites
Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-33165. The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is reclassifying these devices based on the determination that general controls… 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 5, 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 2015-33163. The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP)… 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 5, 2016 Other (Public Domain) 0 reuses 0 favorites
Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-09907. The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is proposing this reclassification based on the tentative determination that general… 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 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
Federal Act of 8 October 2004 on the Transplantation of Organs, Tissues and Cells (Transplantation Act) From Swiss Federal Council 🇨🇠The document is titled "Federal Act on Transplantation of Organs, Tissues, and Cells" and falls under the category of federal constitution, act, or decree. 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 8, 2004 Other (Non-Commercial) 0 reuses 0 favorites
Response letter on issues related to organ preservation fluids From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2002-10124 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 September 17, 2002 Other (Public Domain) 0 reuses 0 favorites