SMDA RULEMAKING DELAYS VIOLATE ADMINISTRATIVE PROCEDURE ACT
This article was originally published in The Gray Sheet
Executive Summary
SMDA RULEMAKING DELAYS VIOLATE ADMINISTRATIVE PROCEDURE ACT, the consumers' group Public Citizen contends in a lawsuit filed against FDA and HHS Oct. 28 in the U.S. District Court for the District of Columbia. Public Citizen charges that FDA's failure to finalize statutorily mandated user facility reporting and 510(k) summary rules under the Safe Medical Devices Act of 1990, as well as failure to fully implement other SMDA provisions, constitutes "unreasonable delay in violation of the Administrative Procedure Act."