Steve Gutman, MD

Strategic Advisor

Steve has more than 30 years of medical industry experience with 15+ years at FDA, where he founded and directed OIVD, the Office of In Vitro Diagnostics. Steve holds a deep understanding of IVD history and regulation from developing policy and representing the agency for many years.

Steve comes to Myraqa from Blue Cross Blue Shield Association, where he has been extending his scope of work as an Associate Director, where he formed scientific valuations and policies.

Steve earned his MD at Cornell University Medical College, MBA with distinction from SUNY at Buffalo and his BS from The Ohio State University.

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Recent Blogs

A First Look at a New Review Paradigm Working the bugs out of new methods for identifying bugs
FDA Announces New EUO Label Draft guidance will lay out new path for devices
Is Apple's Rumored Healthbook a Medical Device? Looking to re-invent the old "Apple a day" saying
Risk-Based Quality Management of Clinical Trials US and EU take (somewhat) similar approaches

Glossary Terms

In Vitro Diagnostic (IVD)
Office of In Vitro Diagnostic Devices (OIVD)