Left to Their Own Devices: IOM's Medical Device Committee's Failure to Comply

Abstract

The Institute of Medicine (IOM) is increasing engaged in policy analysis and recommendations including a current project to assess medical devices and the 510(k) process. In addition to internal IOM policies and good practices, any IOM committee commissioned by a federal agency must abide by FACA Sec. 15. This paper expands upon an earlier paper by these authors regarding issues relating to the IOM 510(k) committee. It examines in more detail the legislative history of FACA Sec. 15, relevant case law and other IOM committees. The authors conclude that the IOM 510(k) committee fails to satisfy FACA Sec. 15. As such FDA is statutorily prohibited from using any report from this committee.

Keywords: Medical Devices, Compliance, Regulation, FDA, IOM