Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs)

This Framework is intended to help test sponsors make decisions on how to develop credible evidence of analytical and clinical validity and clinical utility. It is a product of MDIC’s IVD Clinical Evidence Working Group.

The Framework is organized into five sections, outlined below:

Section One: Introduction – introduces the Framework, definitions of analytical validity, clinical validity, and basic concepts of FDA clearance and approval of medical devices, including IVDs.

Section Two: Analytical Validity – provides a library of tests frequently used to demonstrate analytical validity. Useful terms, test considerations and requirements, and related references are provided.

Section Three: Clinical Validity – discusses assay types and measurements of clinical validation, as well as design considerations for clinical validation based on the intended use of the IVD.

Section Four: Clinical Utility – explores the general strategy for developing evidence of clinical utility for payers, presents a clinical utility “self-assessment” framework that IVD developers can use for planning, and details additional clinical utility considerations by IVD test type.

Section Five: References – lists regulatory documents not provided in-line with the text and other references cited in this Framework.

The scope of the statement of work of this Framework is specific to the United States. This Framework should be considered an initial thought piece and not a prescriptive, “how-to” guide. Reading and following this document neither guarantees FDA approval/clearance nor payment from insurance companies.