A Failure to Comply: An Initial Assessment of Gaps in IOM’s Medical Device Study Committee

Abstract

The Institute of Medicine (IOM) is increasingly engaged in policy analysis and recommendations including a current project to assess medical devices and the 51'6k) 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 examines the issues relating to the composition and processes of the IOM 51'6k) committee and concludes that it fails to satisfy FACA Sec. 15. As such FDA is statutorily prohibited from using any report from this committee.

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