Date Published:
Thu, 11/10/2011The CDRH and CBER branches of the US FDA issued the draft guidance document, FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, for comment on November 10, 2011.
This draft guidance document provides recommendations to industry, clinical investigators, institutional review boards (IRBs), and FDA staff to promote the initiation of clinical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 7, IDE Disapproval, and 8.1, Non-Clinical Testing, for expectations regarding software validation.