Abstract

Revisiting the Point of Care – Changes to U.S. FDA Policies on CLIA Waivers and Opportunities in POCT

James Boiani, Partner, Epstein Becker & Green PC

There have recently been substantial changes for the better in U.S. FDA’s approach to application of CLIA Waiver standards, reflected in new FDA guidance.  Mr. Boiani – a seasoned life sciences attorney and the Founder and General Counsel of the Coalition for CLIA Waiver Reform – will offer his perspectives on FDA’s new approach, the history of its evolution and legal underpinnings, and the opportunities it creates for innovation in the U.S. market.  He will cover key elements of new FDA guidance, including use of agreement studies, human factors evaluations, and dual marketing and CLIA waiver submissions, which could make for a more efficient and accepting regulatory environment.