Paul S. Gadiock - McDermott Will & Emery


Paul Gadiock leverages his firsthand experience at the Food and Drug Administration (FDA) to provide life sciences, healthcare and other FDA-regulated companies with practical, strategic counsel at every phase of the product life cycle. Paul supports medical device, digital therapeutic, and biopharma companies, software as a medical device (SaMD) and clinical decision support (CDS) developers, and their investors on their FDA regulatory and due diligence needs, delivering premarket and postmarket regulatory guidance to maximize business outcomes.

From providing strategic regulatory approval direction at the product concept stage through post-marketing issues such as product marketing, labeling, advertising, and recalls and crisis matters, Paul has substantial experience helping his clients bring novel technologies and innovative products to market. His deep experience allows him to provide practical, business-minded due diligence support to buyers, sellers and investors in achieving their transaction goals.

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  • Represented clients before the FDA on several occasions, successfully persuading the agency to decline regulating client medical products and wellness tools, often after the clients had received regulatory inquiries from FDA*
  • Secured priority regulatory designation for a tissue product client, enhancing FDA interactions and expediting regulatory review of the tissue product’s marketing application*
  • Designed several phased regulatory strategies that position client offerings as consumer products that avoid or minimize FDA oversight to earn revenue while data is being generated to support the products’ future medical claims and/or functionalities*

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University of Maryland Francis King Carey School of Law, JD, 2009
University of Maryland, BS, 2004

District of Columbia