Selected Publications
 
Horwitz, D.M.  2008.  Commentary Classifying Medical Device Data Systems in the US.  RAJ Devices July/August.
Horwitz 2008.pdf -- Click to download, 72 KB
  
Titkemeyer, R. and Mandell, D.  2003.  Corrections and Removals:  Is 21 CFR 806 the Forgotten Regulation?  Regulatory Affairs Journal (Devices) 11(6):339-341.
 
Sumner, K, Baetz, J. and Mandell, D.  2003.  Reprocessed single use devices and third party inspections; changes resulting from MDUFMA.  Regulatory Affairs Journal (Devices) 11(3):145-149.
Sumner et al. 2003.pdf -- Click to download, 476 KG
 
Mandell, D., Zielinski, K., Baetz, J., and Sumner, K.  2003.  New Medical Device User Fees Required in the United States.  Regulatory Affairs Journal (Devices) 11(2):73-79.
Mandell 2003.pdf -- Click to download, 504 KB
 
Mandell, D. and Falk, J.  2002.  Current U.S. Regulation of Combination Products.  Regulatory Affairs Journal (Devices) 10:289-293.
Mandell and Falk 2002.pdf -- Click to download, 496 KB
 
Mandell, D. and Becker, K.  2002.  A Primer on U.S. Marketing Authorisations for Medical Devices – Part 1:  Premarket Notifications.  Regulatory Affairs Journal (Devices) 10:3-11.
Mandell and Becker 2002.pdf -- Click to download, 512 KB
 
Mandell, D.E., McTyre, R.B., DeLustro, F., and Erickson, R.  1998.  "Injectable Collagen and a Rare Adverse Event - True Association or Artifact?:  Results of Postmarket Surveillance Research."  In: Clinical Evaluation of Medical Devices: Principles and Case Studies, K.B.Witkin (ed.).  Totowa, New Jersey: Humana Press.
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