Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, IVDMD, Medical Devices, Radiation-Emitting Products
Topics
Good Clinical Practice (GCP), Premarket
Published
April 25, 2006
Last updated
March 22, 2024
Description
This document provides guidance on informed consent for studies using leftover human specimens, aimed at sponsors, IRBs, and FDA staff.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)