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

18 Pages Posted: 20 Jul 2011  

Ralph Hall, JD

University of Minnesota, Twin Cities - School of Law

Eva Stensvad

affiliation not provided to SSRN

Date Written: May 19, 2011

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

Suggested Citation

Hall, JD, Ralph and Stensvad, Eva, A Failure to Comply: An Initial Assessment of Gaps in IOM’s Medical Device Study Committee (May 19, 2011). Minnesota Journal of Law, Science & Technology, Vol. 12, No. 1, 2011. Available at SSRN: https://ssrn.com/abstract=1889244

Ralph Hall, JD (Contact Author)

University of Minnesota, Twin Cities - School of Law ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States

Eva Stensvad

affiliation not provided to SSRN ( email )

Paper statistics

Downloads
22
Abstract Views
328