Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development: Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for industry on conducting long-term clinical neurodevelopmental safety studies in neonatal product development. 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 July 23, 2024 Other (Public Domain) 0 reuses 0 favorites
ICH guideline E8 (R1) on general considerations for clinical studies From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH E8 (R1); EMA/CHMP/ICH/544570/1998 Corr* 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document outlining clinical considerations for studies of devices treating opioid use disorder, aimed at industry and FDA staff. 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 July 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Laboratory Developed Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-08935. The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.… 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 6, 2024 Other (Public Domain) 0 reuses 0 favorites
Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document discussing enforcement policies for tests during a Section 564 declared emergency, aimed at industry and FDA staff. Focuses on outbreak-related topics. 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 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Ethical Considerations for Clinical Investigations of Medical Products Involving Children: Draft Guidance for Industry, Sponsors, and IRBs From Food and Drug Administration (FDA) 🇺🇸 This document is a draft guidance for industry, sponsors, and IRBs on ethical considerations for clinical investigations involving children. 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 12, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices 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 March 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Researcher considerations for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for the industry and FDA staff on technical considerations for medical devices with closed-loop control technology. 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 October 6, 2023 Other (Public Domain) 0 reuses 0 favorites
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document on premarket submissions for cybersecurity in medical devices, providing quality system considerations. 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 26, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices with Indications Associated with Weight Loss - Clinical Study and Benefit-Risk Considerations: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document for the FDA and industry staff on medical devices related to weight loss, including clinical study and benefit-risk considerations. 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 14, 2023 Other (Public Domain) 0 reuses 0 favorites
Design Considerations for Pivotal Clinical Investigations for Medical Devices: Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on pivotal clinical investigations for medical devices, covering topics like GCP, IDE, and premarket considerations. 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 August 10, 2023 Other (Public Domain) 0 reuses 0 favorites
MDCG 2021-3 - Questions and answers on custom-made devices and considerations for adaptable medical devices and patient matched medical devices From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A document providing guidance on custom-made devices, adaptable medical devices, and patient-matched medical devices, addressing common questions and considerations. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
General Considerations for Animal Studies Intended to Evaluate Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document for industry and FDA staff on conducting animal studies to evaluate medical devices, covering IDE and premarket topics. 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 27, 2023 Other (Public Domain) 0 reuses 0 favorites
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA staff on clinical performance assessment of computer-assisted detection devices in radiology. 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 September 27, 2022 Other (Public Domain) 0 reuses 0 favorites
Software and applications From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A guide discussing considerations related to medical device software and SaMD. 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 November 9, 2021 Other (Public Domain) 0 reuses 0 favorites
ICH Q12: Implementation Considerations for FDA-Regulated Products: Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document by FDA on implementation considerations for FDA-regulated products, focusing on Chemistry, Manufacturing, and Controls (CMC) and Pharmaceutical Quality. 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 September 10, 2021 Other (Public Domain) 0 reuses 0 favorites
Webinar presentation: Remote GMP inspections: Current feedback and future considerations From Therapeutic Goods Administration (TGA) 🇦🇺 A webinar presentation discussing remote GMP inspections, including current feedback and future considerations. Focuses on manufacturing. 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 18, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides technical guidance for the premarket assessment of medical devices containing Nitinol for industry and FDA staff. 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 August 9, 2021 Other (Public Domain) 0 reuses 0 favorites
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for non-clinical testing and clinical considerations of implanted Brain-Computer Interface (BCI) devices for patients with paralysis or amputation. 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 19, 2021 Other (Public Domain) 0 reuses 0 favorites