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FY 2002 ODE Annual Report - Appendix B - ODE Publications

The following is a bibliography of articles and abstracts prepared by the ODE staff and published or presented during FY 2002.

Journals, Newsletter Articles and Book Chapters

Abel, DB, Beebe, HG, Dedashtian, MM, Morton, MC, Moynahan, M, Smith, LJ, and Weinberg, SL. Preclinical Testing for Aortic Endovascular Grafts: Results of a Food and Drug Administration Workshop. J Vasc Surg. 35(15):1022-1028, 2002.

Abel, DB. Medical Device Approvals in the US and Abroad. Endovascular Today 1(1): 48-50, September/October 2002.

Baker, KH. Spotlight on Research: Clinical Study and Literature Review of Nasal Irrigation. ORL Head and Neck Nursing Vol 19:1, Winter 2001.

Boerboom, LE, Barillo, DJ, Coleman, CL, Hottenstein, OD, Beniker, HD, McManus, AT and Livesey, SA. Freeze-Dried, Decellularized Goat Arterial Allograft. Cell Preservation Technology 1(1):53-62, 2002.

Gutman, S. Regulatory Issues in Tumor Marker Development. Seminars in Oncology. 29(3):294-300, 2002.

Heaton, T, Kaiser, S, Peters, K, and Stuhlmuller, J. Intravascular Brachytherapy Devices: FDA Perspective. Medical Physics, 29(6):1317-1318, 2002.

Ho, C. Challenges in Designing a Multi-Function Patient Monitor. Biomedical Sciences Instrumentation 38:71-76, 2002.

Sacks, W.M. Whole-Body CT Screening - Should I or Shouldn’t I Get One? FDA/CDRH Website. 2002.

Zaremba, L. Regulatory Issues in MR Safety. In Special Cross-Specialty Categorical Course in Diagnostic Radiology: Practical MR Safety Considerations for Physicians, Physicists, and Technologists. Edited by Emanuel Kanal, M.D. Radiological Society of North America, 820 Jorie Blvd., Oak Brook, Il 60523, pp. 103-111, 2001.

Abstracts and Presentations

Abel, DB. What the FDA is looking for in Endovascular Graft Clinical Studies. International Symposium on Endovascular Therapy, Miami, FL, January 23, 2002.

Abel, DB. Attack on America: Impact on Endovascular Interventions, a Regulatory Perspective. International Congress XV Endovascular Interventions, Phoenix, AZ, February 11, 2002.

Abel, DB. Concerns and Considerations in the Evaluation of Vascular Devices: A Regulatory Perspective. Issues Session: The Impact of New Technology on Vascular Surgeons and their Patients. Eastern Vascular Society, Boston, MA, May 3, 2002.

Abel, DB. Assessment of Medical Evidence in Relationship to Diffusion of Technology: Approach of the FDA. Euro PCR, the Paris Course on Revascularization, Paris, France, May 21, 2002.

Abel, DB. Evaluation of Endovascular Grafts: USA Requirements and ISO Standards Development. Euro PCR, the Paris Course on Revascularization, Paris, France, May 22, 2002.

Abel, DB. The FDA Office of Device Evaluation’s Role in Device Approval and Labeling. Endovascular Issues Session – Society for Vascular Surgery Annual Meeting, Boston, MA, June 11, 2002.

Baker, K. and Malshet, V. Alternative and Complementary Treatments for Sinusitis. Society of Otolaryngology/Head and Neck Nurses, San Diego, CA, September 23-25, 2002.

Baker, K. Glove Selection: Choosing the Right Glove for the Job. 2002 FDA Science Forum, Washington, DC, February 20-21, 2002.

Barold, HS and Carey, CC. Does the Percentage of Female Patients in Clinical Trials for Implantable Cardioverter Defibrillators Represent the Rates of Sudden Cardiac Death in the United States? FDA Science Forum, Washington, DC, February 20-21, 2002.

Baxley, J. IDE Regulations – Background. Association of Clinical Research Professionals, Toronto, Canada, April 13-17, 2002.

Callaghan, J. and Cooper, J. Alternative Approaches to Product Clearance: Family Member Strategies and 510(k) Processes: Traditional/Special/Abbreviated. 29th Annual Meeting: Association of Medical Diagnostic Manufacturers, Baltimore, MD, April 25, 2002.

Ciarkowski, AA, and Regnault, WF. Background Whitepaper, at the Biomaterials and Medical Implant Science (BIMIS) Workshop on Medical Implant Information, Performance, and Policies, Gaithersburg, MD, September 19 – 20, 2002.

Ciarkowski, AA. Proposed a Strategy for Effective, Safe Use of Devices in Home Settings at an FDA Public Hearing on Home Health Care Devices, Bethesda, MD, September 12-13, 2002.

Durfor, CN. Viral Clearance Issues with Medical Devices: a Reviewer's Perspective. International Association for Pharmaceutical Science and Technology, Washington, DC, September 25, 2002.

Foy, J, Hyde, J, Jensen, DN, Zuckerman, B, and Heaton, T. Best Practices to get an IDE Approved for a Drug-Eluting Coronary Stent. Cardiovascular Revascularization Therapy (CRT) Conference, Washington, DC, February 8, 2002.

Foy, J. Pre-Clinical Standards and Recommended Studies for Drug-Eluting Stents, Transcatheter Cardiovascular Therapeutics (TCT), Washington, DC, September 25, 2002.

Goode, J. FDA Use and Recommended Direction of ASTM Arthroplasty Standards. ASTM Mini Workshop:F04.22-Arthroplasty Subcommittee, Dallas, TX, November 8, 2001.

Gutman, S. FDA's Role in the Regulation of Tests for Pharmacogenomic Drug Testing. Therapeutic Drug Monitoring Renaissance Forum, American Association of Clinical Chemistry, Baltimore, MD, January 25, 2002.

Gutman, S. Update on FDA Activities. CLIAC Meeting, Atlanta, GA, January 30, 2002.

Gutman, S. FDA Options in the Evaluation of Laboratory Tests. Secretary's Advisory Committee on Genetics Testing, Bethesda, MD, February 13, 2002.

Gutman, S. FDA Regulation of In Vitro Diagnostic Devices. Grand Rounds, Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD, March 7, 2002.

Gutman, S. New Initiatives in the Regulation of In Vitro Diagnostic Devices. Association of Medical Diagnostics Manufacturers, Rockville, MD, April 29, 2002.

Gutman, S. The Value of Materials Standards to FDA Regulatory Processes. National Institute of Standards, Gaithersburg, MD, April 30, 2002.

Gutman, S. FDA Regulation of Ner2/neu Testing, Strategic Science 1: Her2/neu Testing of Breast Cancer Patients in Clinical practice, Chicago, IL, May 5, 2002.

Gutman, S. FDA Regulation and the Search for Gold. International Forum on Traceability, Joint Committee on Traceability in Laboratory Medicine, Paris, France, June 11, 2002.

Gutman, S. FDA Role in the Regulation of Laboratory Tests -- An Update on IVDs, ASRs, OTCs, CLIA Waivers and other Wonders of the Regulatory World. Clinical Laboratory Management Association's Annual Meeting, New Orleans, LA, June 29, 2002.

Gutman, S. Panel Member on Traceability in Laboratory Medicine. EDUTRAK program, American Association of Clinical Chemistry, Orlando, FL, July 30, 2002.

Gutman, S. FDA Oversight of Therapeutic Drug Management and Pharmacogenomics Diagnostics” American Association of Clinical Chemistry, Orlando, FL, July 31, 2002.

Gutman, S. FDA Regulations, the Importance of Standards. NCSL International, San Diego, CA, August 7, 2002.

Gutman, S. Panel: Challenges Facing Healthcare Metrology. NCSL International, San Diego, CA, August 7, 2002.

Gutman, S. Update on FDA Activities. CLIAC Meeting, Atlanta, GA, September 11, 2002.

Hackett, JL. Pharmacogenetiacs, FDA, and In Vitro Diagnostics. Pharmaceutical Research and Manufacturers of America. (PhRMA) Biologics and Biotechnology Fall Meeting, Washington, DC, October 24, 2001.

Hackett, JL. Panel Member for General Session: Evolving Roles, Opportunities and Challenges for Chips. International Business Communications. Eighth Annual Chips to Hits, San Diego, CA, October 29, 2001.

Hackett, JL. FDA Oversight of Genetic Testing. National Society of Genetic Counselors. Washington, DC, November 5, 2001.

Hackett, JL. Regulatory Compliance for TDM and Pharmacogenomics Test Development - Current and Future Strategy. American Association of Clinical Chemistry, Therapeutic Drug Monitoring Renaissance Forum, Baltimore, MD, January 25, 2002.

Hackett, JL. Panel Member for Breakout Session – Genomics. 2002 FDA Science Forum, Washington, DC, February 20, 2002.

Hackett, JL. FDA Oversight of Genetic Testing. American College of Medicinal Genetics Annual Clinical Genetics Meeting, New Orleans, LA, March 16, 2002.

Hackett, JL. Regulatory Challenges for the New Molecular Diagnostics. International Business Communications Fifth International Conference for Microarrays for Diagnostics, San Diego, CA, March 21, 2002.

Hackett, JL. Pharmacogenetics, and the U.S. FDA. Canadian Institute of Health Research. Symposium in Genomics and Public Policy, Toronto, Canada, June 8, 2002.

Hackett, JL. FDA and In Vitro Clinical Devices. 2002 Taipei International Masters Forum on Biotechnology, Taipei, Taiwan, June 26, 2002.

Heaton, HT, Kaiser, S and Peters, K. IVB - Why dosimetry is Important. CIRMS Workshop on Intravascular Brachytherapy Sources, National Institute of Standards and Technology, Gaithersburg, MD, October 29-31, 2001.

Heaton, T, Kaiser, S, Peters, K, and Stuhlmuller, J. “Intravascular Brachytherapy Devices: FDA Perspective”, 44th Annual Meeting of the American Association of Physicists in Medicine, Montreal, Canada, July 14-18, 2002.

Ho, C. Challenges in Designing a Multi-Function Patient Monitor. Rocky Mountain Bioengineering Symposium, Copper Mountain, CO, April 2002.

Ho, C worked on an Association for the Advancement of Medical Instrumentation (AAMI) standard "Standard communications protocol-- Computer assisted electrocardiography", ANSI/AAMI EC71:2001.

Jevtich, M. & Morris, J. U. S. Regulatory Considerations for New Device Technologies for the Treatment of Localized Prostate Cancer. 3rd International Consultation on Prostate Cancer, Paris, France, June 30, 2002.

Kane, J. Otoacoustic Emissions. Society of Otolaryngology/Head and Neck Nurses, Rockville, MD, May 2002.

Mann, E. FDA Activities Related to Meningitis in Cochlear Implant Recipients. 7th International Cochlear Implant Meeting, Manchester, U.K., September 2002.

Ogden, NR. Telemedicine and Robotics. SCIOT/SIROT 2002 XXII World Congress Meeting, San Diego, CA, August 29, 2002.

Ogden, NR. System Approach to Validation and Regulatory Approval. NIH/NSF Workshop on Image Guided Interventions, Bethesda, MD, September 12-13, 2002.

Pluhowski, N. Conducting an FDA Advisory Panel Meeting. Regulatory Affairs Professional Society (RAPS), Baltimore, MD, 2001

Pluhowski, N. Overview of PMA Regulations. Regulatory Affairs Professional Society (RAPS) Premarket Approval (PMA) Workshop, San Francisco, CA, March 2002.

 


Pluhowski, N. How to Prepare for Successful Panel Meetings. Regulatory Affairs Professional Society (RAPS) Premarket Approval (PMA) Workshop, San Francisco, CA, March 2002.

Pluhowski, N. Post-PMA Activities. Regulatory Affairs Professional Society (RAPS) Premarket Approval (PMA) Workshop, San Francisco, CA, March 2002.

Pluhowski, N. Hot Topics: PMAs. Regulatory Affairs Professional Society (RAPS) Medical Device Conference & Tabletop Exhibition, San Francisco, CA, March 2002.

Pluhowski, N. Product Submissions - Expectations and Preparation for an FDA Advisory Panel Meeting. The 5th Annual FDA-OCRA (Orange County Regulatory Affairs) Educational Conference, Irvine, CA, June 2002.

Pluhowski, N. Public Availability of Information Prior to a Panel Meeting. Advanced Medical Technology Association (AdvaMed) 12th Annual Device Submission Workshop, Rockville, MD, June 2002.

Pollard, C. FDA Law and Clinical Development of Devices. American Society of Reproductive Medicine, Orlando, FL, October 23, 2001.

Pollard, C. Clinical Development of Medical Devices: A Regulatory Perspective. Diaphragm Renaissance Workshop, Seattle, WA, September 10, 2002.

Rechen, E.J. Third Party Review of 510(k)s. Medical Design and Manufacturing (MD&M) Minneapolis Conference, Minneapolis, MN, October 2001.

Rechen, E.J. FDA – Advanced and Hot Topics in 510(k) Submissions. Medical Design and Manufacturing (MD&M) Minneapolis Conference, Minneapolis, MN, October 2001.

Rechen, E.J. Contents of a Successful Premarket Submission. Medical Design and Manufacturing (MD&M) Minneapolis Conference, Minneapolis, MN, October 2001.

Rechen, E.J. Third Party Review of 510(k)s. Medical Design and Manufacturing (MD&M) East Conference, New York City, NY, June 2002.

Rechen, E.J. Third Party Review Program Update. AdvaMed’s 12th Annual Device Submissions Workshop, Rockville, MD, June 2002.

Rosenthal, A.R. and Eydelman, M. Regulation of Medical Devices. Annual Meeting of American Academy of Ophthalmology, New Orleans, LA, November 2001.

Rosenthal, A.R. and Daynard, M. Refractive Surgery Advertising Guidelines. Federal Trade Commission, New Orleans, LA, November 2001.


Rosenthal, A.R. FDA Regulation of the Medical Device Industry. Houston Ophthalmological Society, Houston TX, December 2001.

Sacks, W.M. Computers Versus Radiologists. American Association of Physicists in Medicine (AAPM), Montreal, Canada, July 2002.

Saviola, J. The Ophthalmic Device Evaluation and Approval Process. The Eye and the Chip Conference, Detroit, MI, June 2002.

Saviola, J. The FDA’s Role in Contact Lens Development and Safety. Continuous Wear Contact Lenses for the New Millennium, San Diego, CA, August 2002.

Shulman, M. New Tools for Successful 510(k) Submission. Medical Design and Manufacturing (MD&M) West Conference, Anaheim, CA, February 2002.

Shulman, M. Premarket Notification. AMDM In Vitro Diagnostics 510(k) Workshop, Rockville, MD, April 2002.

Shulman, M. Tools for Successful Premarket Notification Submissions. Medical Design and Manufacturing (MD&M) East Conference, New York City, NY, June 2002.

Shulman, M. 510(k) Submission 101. AdvaMed, Washington, DC, February 2002.

Shulman, M. 510(k) Submission 101. AdvaMed, Irvine, CA, August 2002.

St. Pierre, DJ., Sutton, W., Shulman, M., Cooper, J., Dubois, D., Poole, F., Bautista, J., Altaie, S., Sliva, C., Collins, B., and Cowan, E. Association of Medical Diagnostics Manufacturers 510(k) Workshop, Rockville, MD, April 23-24, 2002.

St. Pierre, DJ. Breakout Session - DCLD. AdvaMed 12th Annual Submissions Workshop, Rockville, MD, June 7, 2002.

St. Pierre, DJ. Training at the FDA and DCLD Update. Association of Medical Diagnostics Manufacturers - IVD Focus XI Meeting, San Diego, CA, September 20, 2002.

Whipple, D. FDA Update. American National Standards Institute (ANSI) Committee Z80 for Ophthalmic Device Standards, Baltimore, MD, October 2001 and Ft. Lauderdale, FL, March 2002.

Witten, CM. ASPS Hot Topic Forum, Orlando, FL, November 3, 2001.

Witten, CM. CDRH Regulation of Tissue Based Products: The Who, What, When, Where, Why & How. Raps Medical Device Conference, San Francisco, CA, March 19, 2002.

Witten, CM. FDA Requirements in Planning and Conducting a Clinical Trial - The Clinical Site, Washington, DC, April 6-7, 2002.

Witten, CM. Tissues in Devices, Human Tissue Establishment Inspection, Columbia, MD, June 3, 2002.

Witten, CM. Deep Brain Stimulation for Parkinson's Disease, The Medicare Coverage Advisory Committee, Baltimore, MD, June 12, 2002.

Yustein, A. FDA and Gastroenterology Devices. Society of Gastroenterology Nurses and Associates, Williamsburg, VA, March 2002.

Zaremba, L. FDA Guidelines for Magnetic Resonance Equipment Safety. Annual Meeting of the American Association of Physicists in Medicine (AAPM), Montreal, Canada, July 16, 2002.

Zaremba, L. Abstract. FDA Guidelines for Magnetic Resonance Equipment Safety. Medical Physics 29(6):1302, June 2002.

Zimmerman, B. FDA Update. Orthopedic Surgical and Manufacturers Association, Alexandria, VA, April 10, 2002.

Zimmerman, BZ. FDA Regulation of Orthopedic Devices. The International Society for Orthopedic Surgery and Traumatology, San Diego, CA, August, 2002.

Staff College Presenters and Faculty

 

Abel, Dorothy
Barold, Helen
Barrett, Susanna
Berman, Michael
Cygnarowicz, Teresa
Eydelman, Malvina
Gantt, Doyle
Harvey, Elisa
Hawthorne, C. Ann
Jensen, D. Nick
Kammula, Raja
Kane, James
Kennell, Lisa
Lacy, Frank
Less, Joanne
McCool, Barbara
Melkerson, Mark
Mitchell, Diane
Morris, Janine
Moynahan, Megan
Nell, Diane
Nutter, Cathy
Nguyen, Thinh
Phillips, Robert
Provost, Miriam
Rosecrans, Heather
Sacks, William
Stewart, Sandy
Swain, Julie
Tillman, Donna-Bea
Virmani, Mridulika
Warburton, Karen
Whang, Joyce
Witten, Celia
Yustein, Ron