21 CFR Chapter I Subchapter H – Medical Devices – Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) 🇺🇸 Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. 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 days ago Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-20999. The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric continuous renal replacement therapy system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of 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 3 days ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 882 Neurological Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 882 Neurological 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
21 CFR Chapter I Subchapter H – Medical Devices – Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Research Involving Children as Subjects and Not Otherwise Approvable by an Institutional Review Board: Process for Referrals to Food and Drug Administration and Office for Human Research Protections: Draft Guidance for Institutional Review Boards, Investigators, and Sponsors From Food and Drug Administration (FDA) 🇺🇸 A draft guidance document outlines the process for referring research involving children to the FDA and OHRP, focusing on pediatric product development. 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 April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on premarket assessment of pediatric medical devices. 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 April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Providing Information about Pediatric Uses of Medical Devices: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on providing information about pediatric uses of medical devices in premarket. 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Pediatric Information for X-ray Imaging Device Premarket Notifications: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for industry and FDA staff on premarket notifications for pediatric X-ray imaging devices. 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Pediatric Expertise for Advisory Panels - Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing expertise for advisory panels on pediatric matters, aimed at FDA staff and industry professionals. 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for leveraging clinical data to support the use of medical devices in pediatric populations. 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-28430. The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric Autism Spectrum Disorder (ASD) diagnosis aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of 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 30, 2022 Other (Public Domain) 0 reuses 0 favorites
General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-30193. The Food and Drug Administration (FDA) is issuing a final rule to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also establishing a separate classification regulation for medical bassinets, previously… 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
General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-25627. The Food and Drug Administration (FDA) is proposing to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also proposing to establish a separate classification regulation for medical bassinets, previously… 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, 2015 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems; Republication From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-02049. The Food and Drug Administration (FDA or the Agency) is republishing in its entirety a final order entitled "Effective Date of Requirement for Premarket Approval for Automated External Defibrillator" that published in the Federal Register on January 29, 2015 (80 FR… 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 3, 2015 Other (Public Domain) 0 reuses 0 favorites
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-01619. The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED 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 January 29, 2015 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure From Food and Drug Administration (FDA) 🇺🇸 Document number 2014-00267. The Food and Drug Administration (FDA) is issuing a final rule amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that… 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 10, 2014 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure From Food and Drug Administration (FDA) 🇺🇸 Document number 2013-03647. The Food and Drug Administration (FDA) published a proposed rule in the Federal Register of April 1, 2010, along with a companion direct final rule. The proposed rule proposed to amend the regulations on premarket approval of medical devices to include requirements… 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 19, 2013 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure; Direct Final Rule From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-7193. The Food and Drug Administration (FDA) is amending the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended… 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 1, 2010 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure From Food and Drug Administration (FDA) 🇺🇸 Document number 2010-7192. The Food and Drug Administration (FDA) is proposing to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device 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 April 1, 2010 Other (Public Domain) 0 reuses 0 favorites
The 2nd Term Science Board (FY2014, FY2015) From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 A document discussing the activities and focus areas of the 2nd Term Science Board for fiscal years 2014 and 2015, including regulatory science and standard development. 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites