FDAnews
www.fdanews.com/articles/138341-company-seeks-court-relief-for-fda-determination-of-combination-product

Company Seeks Court Relief for FDA Determination of Combination Product

July 13, 2011
French manufacturer Prevor is suing the FDA, claiming it overstepped its authority by naming Center for Drug Evaluation and Research (CDER) the primary review center, rather than CDRH, for the company’s combination product.
Devices & Diagnostics Letter