FDAnews
www.fdanews.com/articles/138315-wlf-iom-510-k-panel-may-not-meet-requirements-of-faca

WLF: IOM 510(k) Panel May Not Meet Requirements of FACA

July 12, 2011
Free-enterprise advocate the Washington Legal Foundation (WLF) says the FDA may be violating the Federal Advisory Committee Act (FACA) if it follows advice from the Institute of Medicine (IOM) on how to improve the 510(k) process.
Devices & Diagnostics Letter