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- Gong XY, Chwirut DJ, Mitchell MR, Choules BD: "Fatigue to Fracture: An Informative, Fast, and Reliable Approach for Assessing Medical Implant Duability," J ASTM International, 2009; 6(7): 1-10.
- Harvey, E, Oktay S, Chwirut, D, and Danielson, J: "How to Submit Preclinical Data to ODE," MD&DI, July 2008.
- Harvey, ED: "Resolving Disputes with Your US FDA Review Team," J Medical Device Regulation, May 2008.
- Harvey, ED: "You Have Met with the US FDA - Now What?," J Medical Device Regulation, November 2007.
- Harvey, ED: "Successfully Interacting with the US FDA," J Medical Device Regulation, May 2007.
- Harvey, ED, Herman, WA, and Mendelson, M: "Food
and Drug Administration (U.S. FDA) Medical Device Research Considerations. Touch Briefing," Drug Development, accepted
for publication March 2006.
- Kaplan, AV, Harvey, ED, Kuntz, R, Shiran, H, Robb, JF, and Fitzgerald, P: "Humanitarian Use
Devices (HUD)/Humanitarian Device Exemptions (HDE) in Cardiovascular Medicine," Circulation, vol 112, 2005.
- Oktay HS, Ryan T, and Chwirut DJ: “A Chronical of the U.S. Regulatory Process of Stent
Approval,” in Textbook of Coronary Stenting, Eds. Stone GW and
Leon MB, under development.
- Perry M, Oktay S and Muskivitch J: "Finite Element Analysis and Fatigue
of Stents," Minim Invas Ther Allied Tech, accepted for publication.
- Harvey, ED and Whang, JM: "Preclinical Testing Guidelines for New Abdominopelvic Adhesion Barriers," Infertility and Reproductive Medicine Clinics of North America, vol 14, 2003.
- Oktay S, Perry M, and Muskivitch JC: "Using Mechanical Simulations to
Improve the Design of Implantable Devices," Am J Cardiol,
vol 90 (Suppl 6A), 2002.
- Choma TJ, Chwirut DJ and Polly DW: “Biomechanics of LongSegment Fixation: Hook Patterns and Rod Strain”, J Spinal Disorders, vol 14 (2),
2001.
- Spyker DA, Harvey ED, Harvey BE, Harvey AM, Rumack BH, Peck CC, Atkinson AJ, Woolsey RL, Abernathy DR, and Cantilena LR: "Commentaries: Assessment and Reporting of Clinical
Pharmacology Information in Drug Labeling," Clinical Pharmacology and Therapeutics, vol 67(3), 2000
- Walsh DL, Chwirut DJ and Kotz RM: “EnvironmentalDegradation of Natural Rubber Latex Gloves: The Effects of Elevated Temperature
on Tensile Strength,” ASTM J Test Eval, vol 27(6), 1999.
- Chwirut DJ, Oktay HS and Ryan T: “Nitinol InterventionalCardiology Devices - FDA’s Perspective”, in SMST-97: Proceedings of the
Second International Conference on Shape Memory and Superelastic Technologies,
published by the International Organization on Shape Memory and Superelastic
Technologies, 1997.
- Johnson DM, Chwirut DJ and Regnault WF: “FDA’sRequirements for In-Vitro Performance Data for Prosthetic Heart Valves”,
J Heart Valve Disease, vol 3, 1994.
- OktayHS, Resar J and Humphrey JD: "Luminal Gain Following Balloon Angioplasty Of Normal Coronaries With
Increased Balloon Size Is Offset By Increased Arterial Recoil," American College
of Cardiology, 43rd Annual Scientific Session, 1993.
- Oktay HS, Resar J and Humphrey JD: "Mechanics
of conventional and thermal balloon angioplasty," Bioengineering Conference,
Colorado. ASME, New York, BED-Vol.24,1993.
- OktayHS et al, "Changes in the mechanical
behavior of arteries following balloon angioplasty," Biomechanics
Symposium, Eds. RL Spilker and MH Friedman, ASME, New York, 1991.
- Kien GA, Jeffries B, Katz HV, Herman BA, Carey RF,Chwirut DJ, and Bushar HF: “Digital Acoustical Analysis of Normal and Bimodal
Bjork-Shiley 60-degree Convexo-Concave Heart Valves”, Am J Cardiol, vol 66, 1990.
- Chwirut DJ and Regnault WF: “Fracture Mechanics Principles Applied to Implant Medical Devices - A Review”, Medical Progress
Through Technology, vol 14, 1988.
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