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.
Titkemeyer and Mandell 2003 Corections and Removals RAJ Devices.pdf -- Click to download, 452 KB
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.
