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RESOURCE LIBRARY

Colorful Books

Clinical Trial Guidance

FDA guidance on the design of Pivotal IVD Clinical Studies

FDA guidance on significant or non-significant risk studies (2006)

FDA guidance on Clinical Investigator Financial Disclosure

Informed Consent FDA Guidance (2012)

Companion Diagnostics

Draft FDA guidance on Companion Diagnostics

FDA IDE Approval Process Guidance

Product Development

Design Control Guidance (1997)

IVD Regulatory Guidance

Overview of FDA regulations for IVDs

Assistance from FDA (Device Advice)

IVD Labeling Guidelines

Pre-Submission meetings, FDA Guidance (2012)

Listing of FDA approved Nucleic Acid Based Test

CLIA Guidance

Understanding Food and Drug Administration regulatory requirements for an investigational device exemption for sponsor-investigators (Holbein,ME, Berglund JP)

FDA Guidance on Investigator Responsibilities for Significant Risk Studies

FDA Guidance on Sponsor's Responsibilities for Significant Risk Studies

MRNDx Dataset Archive

Ab Archive Data

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