What Breakthrough Designation Does and Doesn't Do for an IVD

What does FDA Breakthrough Device designation mean for an in vitro diagnostic (IVD)? Learn what it takes to qualify, what evidence supports a request, and how designation can shape development and clinical study planning.
In this episode of Expert Insights, Dan Simpson, RAC, Director of Regulatory Affairs at DCN Dx, joins host Emily Friedland, Vice President of Clinical Research, to discuss the practical benefits and limitations of FDA’s Breakthrough Devices Program.
They cover:
-How clinical utility, unmet needs, and access to care inform a Breakthrough request.
-What evidence to include, and why more data isn’t always more useful.
-Priority review, FDA sprint discussions, and clinical protocol agreements.
-How 510(k) and De Novo pathways affect intended use and development decisions.
-FDA’s READI-Home Innovation Challenge and the potential role of home-use diagnostics in reducing hospital readmissions.
-When to seek regulatory input before committing to a clinical study.
The conversation examines how earlier FDA engagement can help developers clarify evidence expectations while working toward marketing authorization.
To discuss whether your diagnostic may meet the Breakthrough criteria, contact DCN Dx.
Subscribe to Expert Insights for conversations about diagnostic development, clinical research, and regulatory strategy.
#IVD #RegulatoryAffairs #Diagnostics