Abstract

http://ssrn.com/abstract=1889244
 


 



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


Ralph Hall, JD


University of Minnesota, Twin Cities - School of Law

Eva Stensvad


affiliation not provided to SSRN

May 19, 2011

Minnesota Journal of Law, Science & Technology, Vol. 12, No. 1, 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.

Number of Pages in PDF File: 18

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

Accepted Paper Series


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Date posted: July 20, 2011  

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: http://ssrn.com/abstract=1889244

Contact Information

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 )
Feedback to SSRN


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