AIPLA Annual Meeting Joint Biotechnology Committee/ Special Committee on FDA Law Program October 21, 2010 Marriott Wardman Park Hotel – Washington, DC. FDA Regulation of Diagnostic Tests. Jeffrey N. Gibbs Hyman, Phelps & McNamara, P.C. Washington, DC [email protected] Introduction.
To sum up: Can determine whether PMA or 510(k), what data need to be collected (time and cost), reimbursement coverage, and marketing strategy.