Resource Library
Clinical Trial Guidance
IVD Regulatory Guidance
Companion Diagnostics
CLIA Certification Guidance
IDE Guidance
FDA Guidance on IDE Policy and Procedure
FDA IDE Approval Process Guidance
Holbein ME, BerglundJP. Understanding Food and Drug Administration regulatory requirements for an investigational device exemption for sponsor-investigators. J Investig Med. 2012;60:987-94.
FDA Guidance on Investigator Responsibilities for Significant Risk studies
FDA Guidance on Sponsor’s responsibilities for Significant Risk studies
Product Development
Design Control Guidance (1997)