Software and artificial intelligence (AI) as a medical device From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). 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 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Meetings with the Office of Orphan Products Development: Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for industry, researchers, patient groups, and FDA staff on meetings with the Office of Orphan Products 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 April 11, 2024 Other (Public Domain) 0 reuses 0 favorites
Researcher considerations for medical devices From Therapeutic Goods Administration (TGA) π¦πΊ 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
SME guidance material From Therapeutic Goods Administration (TGA) π¦πΊ SME Assist provides a range of guidance material to help small to medium enterprises (SMEs), researchers and start-ups. 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 September 15, 2021 Other (Non-Commercial) 0 reuses 0 favorites
SME Assist From Therapeutic Goods Administration (TGA) π¦πΊ SME Assist is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with therapeutic goods regulation understand their regulatory and legislative obligations. 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 September 15, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on Certificates of Confidentiality for sponsors, investigators, researchers, 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 November 13, 2020 Other (Public Domain) 0 reuses 0 favorites
Useful resources for business and researchers From Therapeutic Goods Administration (TGA) π¦πΊ This page helps point you in the right direction of where you might go to receive support and information at different stages of the product lifecycle. 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 11, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Researcher considerations From Therapeutic Goods Administration (TGA) π¦πΊ Regulatory requirements for researchers of new therapeutic goods, including medicines, medical devices and biologicals. 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 11, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Form FDA 3674 is a guidance document for sponsors, industry, researchers, investigators, and FDA staff on certifications accompanying drug, biological product, and device applications/submissions. 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 January 21, 2020 Other (Public Domain) 0 reuses 0 favorites