FDA Guidance: FDA Decisions for Investigational Device Exemption Clinical Investigations, 8/14
$0.00
The CDRH and CBER branches issued this FDA Guidance FDA Decisions for Investigational Device Exemption Clinical Investigations, on August 19, 2014.
This guidance document provides recommendations to industry, clinical investigators, institutional review boards (IRBs), and FDA staff to promote the initiation of clinical investigations to evaluate medical devices under FDA’s Investigational Device Exemptions (IDE) regulations, Title 21 Code of Regulations (CFR) Part 812.
See sections 6, IDE Disapproval, for expectations regarding software validation.
| Issuing Body | FDA Guidance Documents |
|---|
You may also like…
-
FDA Guidance: Investigational Device Exemptions for Early Feasibility Medical Device Studies, 10/13
2013 FDA guidance to industry, clinicians, and innovators, regarding Investigational Device Exemptions (IDE) applications for early feasibility studies of high risk devices
$0.00 Add to cart -
FDA Guidance: Contents of Premarket Submissions for Management of Cybersecurity in Medical Devices, 10/14
In October, 2014 the FDA published this guidance to the cybersecurity issues that manufacturers should consider in the design and development of their medical devices.
$0.00 Add to cart -
FDA Guidance: Inspection of Clinical Investigators, 6/10
Published in June, 2010 to provide information about FDA inspections of clinical investigators conducted under FDA’s Bioresearch Monitoring (BIMO) Program.
$0.00 Add to cart
