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

32 Pages Posted: 20 Jul 2011

See all articles by Eva Stensvad

Eva Stensvad

affiliation not provided to SSRN

Ralph Hall, JD

University of Minnesota, Twin Cities - School of Law

Date Written: July 1, 2011

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

Suggested Citation

Stensvad, Eva and Hall, JD, Ralph, Left to Their Own Devices: IOM's Medical Device Committee's Failure to Comply (July 1, 2011). Minnesota Journal of Law, Science & Technology, Vol. 13, No. 1, 2012 , Available at SSRN: https://ssrn.com/abstract=1889255

Eva Stensvad

affiliation not provided to SSRN ( email )

Ralph Hall, JD (Contact Author)

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

229 19th Avenue South
Minneapolis, MN 55455
United States

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