FDA Guidance: Investigational Device Exemptions for Early Feasibility Medical Device Studies, 10/13
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The CDRH branch of the US FDA issued the FDA Guidance Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies, on October 1, 2013.ﾠ
This guidance document provides recommendations to industry, clinicians, clinical innovators, and FDA staff regarding the development and review of Investigational Device Exemption (IDE) applications for early feasibility studies of significant risk devices.
For computer and software references, see:
- Section 6, Report of Prior Investigations, for expectation to include software validation and verification as part of basic device safety
- Section 6.2, Design Concept, for expectation to include software documentation as part of the device design concept
- Section 6.5, In Vivo Animal Studies, for discussion regarding use of computer simulation as substitution for live animal studies
| Issuing Body | FDA Guidance Documents |
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