FY 2003 ODE/OIVD 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 2003.

Journals, Newsletter Articles and Book Chapters

Abel DB. Ongoing FDA Evaluation of Approved Endovascular Grafts. J Vasc Surg. 37(4):902-903, 2003.

Abel DB. FDA Advisory Panels. Endovascular Today 1(2):63-65, 2002.

Abel DB. Investigational Device Exemptions. Endovascular Today 2(1):51-52, 2003.

Abel DB. Off-label Medical Device Use. Endovascular Today 2(2):60-61, 2003.

Abel DB. Expanded Access. Endovascular Today 2(3):67-68, 2003.

Abel DB and Smith LJ. The ISO Standard for Endovascular Grafts. Endovascular Today 2(5):56-58, 2003.

Abel DB. Crime and Punishment. Endovascular Today 2(6):84-86, 2003.

Arepalli SR, Bezabehm S, and Brown SL. Allergic Reaction to Platinum in Silicone Breast Implants. J Long-Term Effects of Medical Implants 12(4):299-306, 2002.

Ashar BS and Schultz D. Surgical Technology: A Perspective from the FDA. Bulletin of the American College of Surgeons 88(3):32-33, 2003.

Baker KH. Of Special Interest: The Food and Drug Administration: A Partner in Safe Practice. ORL Head and Neck Nursing 21(2):25-27, Spring 2003.

Baker KH. Of Special Interest: A Review of Research Strategies for Clinicians. ORL Head and Neck Nursing 20(3):23-24, 2002.

Boam AB, Eydelman MB, Lum FC, Silverman PM, Apple DJ, Werner L, and Pandey SK. Retrospective Evaluation of Intraocular Lenses In Adults Younger Than 60 Years. J Cataract Refract Surg. 29(3):575-587, 2003.

Burnett TA, Mann EA, Cornell SA, and Ludlow CL. Laryngeal Elevation Achieved by Neuromuscular Stimulation at Rest. J Appl Physiol 94(1):128-134, 2003.

Chesler NC and Enyinna OC. Particle Deposition in Arteries Ex Vivo: Effects of Pressure, Flow, and Waveform. J Biomechanical Engineering 125:(3)389-394, 2003.

Ciarkowski AA. Empowering Patients: Total Product Life Cycle for Medical Devices.
In Information Technology Business Models for Quality Health Care: An EU/US Dialogue. Edited by S. Krishna, E.A. Balas, and S.A. Boren, IOS Press, Amsterdam, 2003.

Drum B. Aberration Analyses Needed for FDA Evaluation of Safety and Effectiveness of Wavefront-Guided Refractive Surgical Devices. J. Refract. Surg. 19(5):S588-S591, September/October 2003.

Harvey ED and Whang JM. Preclinical Testing Guidelines for New Abdominopelvic Adhesion Barriers. Infertility and Reproductive Medicine Clinics of North America 14: 481-487, 2003.

Ho C and Kurtzman SB. Issues in Using Databases of Pre-recorded Physiological Signals to Test Medical Devices. Biomedical Sciences Instrumentation 39:169-174, 2003.

Holden JP, Selbie WS, and Stanhope SJ. A Proposed Test to Support the Clinical Movement Analysis Laboratory Accreditation Process. Gait and Posture 17(3):205-213, 2003.

Malshet V. Ear Candles: FDA's Regulatory Action and Current Position. American Academy of Otolaryngology-Head and Neck Surgery Bulletin, June 2003.

Ogden N. FDA Regulation of Technology and Surgical Devices in the Operating Room. Seminars in Laparoscopic Surgery 10(3):115-119, September 2003.

Payne C, Van Kerrebroeck P, Blaivas J, Herrera H, Chaikin D, Jonas U, Kusek L, Mattiasson A, Nyberg L, Peters T, Stothers M-A, and Webers A. Research Methodology in Urinary Incontinence. In Incontinence. Edited by P. Abrams, L. Cardozo, S. Khoury, and A. Wein. 2nd International Consultation on Incontinence. 2nd Edition 2002.

Pilcher G, Abel DB, and Homire SA. The FDA Medical Device Fellowship Program. Endovascular Today 2(4):59-61, 2003.

Preminger GM, Pearle MS, Stoller M L, Dore B, Herrera H, Herhej S, and Tolley DA. Quantification of Stone Patient. In Stone Disease. Edited by J. Segura, P. Conort, S. Khoury, C. Pak, G.M. Preminger, and D. Tolley. 1^st International Consultation on Stone Disease. Edition 2003.

Puls I, Jonnakuty C, LaMonte BH, Holzbaur EL, Tokito M, Mann E, Floeter MK, Bidus K, Drayna D, Oh SJ, Brown RH, Ludlow C, and Fishbeck KH. Mutant Dynactin in Motor Neuron Disease. Nature Genetics 33(4):455-456, 2003.

Reefhuis J, Honein MA, Whitney CG, Chamany S, Mann EA, Biernath K, Broder K, Manning S, Avashia S, Victor M, Costa P, Devine O, Graham A, and Boyle C. Risk of Bacterial Mengitis in Children with Cochlear Implants. New Engl J Med 349(15):435-45, 2003.

Sacks W. Estimating the Effect of Computer-Aided Detection on Sensitivity of Screening Mammography. Radiology 226(2):597-598, February 2003.

Saviola J. Guest Perspective Editorial - Contact Lens Adverse Event Reporting. Contact Lens Spectrum 18(6):15, June 2003.

Saviola J. Soft Plano Contact Lenses: Medical Devices or Not? Review of Optometry 140(4): April 2003.

Saviola J. A Closer Look at FDA Contact Lens Labeling, Contact Lens Spectrum 18(1):44, January 2003.

Saviola J, Hilmantel G and Rosenthal AR. The U.S. Food and Drug Administration's Role in Contact Lens Development and Safety. Eye and Contact Lens 29(1):S160-S165, January 2003.

Toy J, Norton JS, Jibodh SR, and Adler R. Effects of Homeobox Genes on the Differentiation of Photoreceptor and Nonphotoreceptor Neurons. Investigative Ophthalmology and Visual Sciences 43(11):3522-9, November 2002.

Wagner RF, Beiden SV, Campbell G, Metz CE, and Sacks W. Assessment of Medical Imaging and Computer-assist Systems: Lessons from Recent Experience. Academic Radiology 9(11):1264-77, November 2002.

Abstracts and Presentations

Abel DB. Similarities and Differences Between the US and European Regulatory Processes. International Symposium on Endovascular Therapy, Miami, FL, January 20, 2003.

Abel DB. CARESS and Discussion of the FDA Versus CE Mark in the Regulatory Process: There is a Difference. Does it Matter? International Congress XVI Endovascular Interventions, Phoenix, AZ, February 11, 2002.

Abel DB. Biomaterials Educational Needs: A Regulatory Perspective. 2003 Society for Biomaterials Workshop entitled "Pathways to Successful Careers: Improving the Interface between Industry and Academia Through Education," Reno, NV, April 30, 2003.

Abel DB. Preclinical Testing: What Does the FDA Believe is Required? Endovascular 2003 and Beyond, Salt Lake City, UT, July 20, 2003.

Abel DB. Regulatory Issues for Graft and Stent Graft Design. Stent Technologies in Endoluminal Therapies Summit, Cleveland, OH, September 11, 2003.

Abel DB. Regulation of Endovascular Grafts: Lessons from the Last Few Years. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Baker K. Alternative and Complementary Treatments the Symptoms of Sinusitis. Society of Otolaryngology and Head and Neck Nurses, San Diego, CA, September 2002.

Berman M. FDA Issues in the Evaluation of New Devices for Acute Heart Failure and Cardiogenic Shock. Transcather Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Boam A. Common Questions Asked of FDA. Town Hall Meeting with FDA CRT 2003, Washington, DC, January 28, 2003.

Boam A. Drug-Eluting Stents: Drug Substance - New vs. Approved. Town Hall Meeting with FDA at CRT 2003, Washington, DC, January 29, 2003.

Boam A. Evolving Regulatory Pathways for Coronary Drug-Eluting Stents. CRF Drug-Eluting Stent Symposium at the American College of Cardiology Annual Meeting, Chicago, IL, March 26, 2003.

Boam A. Drug-Eluting Stents - Current Approach to Review. FDA Workshop: Innovative Systems for Delivery of Drugs and Biologics, Bethesda, MD, July 8, 2003.

Boam A. Current and Evolving Regulatory Considerations for Biomarker Endpoints in AMI Device Trials. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 2003.

Boam A. Drug-Eluting Stent Clinical Trials: Round 2. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Boam A. Articulating the FDA Approval Pathway for a Drug-Eluting Stent System. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 19, 2003.

Bowley SM and Malinauskas RA. Evaluation of Parameters Affecting Bovine Blood Hemolysis Testing. ASME Summer Bioengineering Conference, Key Biscayne, FL, June 25-29, 2003.

Carey CC. Innovations in AED Technology: The Need for Clinical Data. The 7th Wolf Creek Conference on Cardiopulmonary Resuscitation, Rancho Mirage, CA, June 13-16, 2003.

Cricenti P. Regulatory Issues of Needle Destruction Devices, Global Alliance for Vaccines and Immunization Research and Development Task Force New Technologies Group, Geneva, Switzerland, October 28-29, 2002.

Cricenti P. Regulatory Issues of Needle Destruction Devices, Global Alliance for Vaccines and Immunization Research and Development Task Force New Technologies Group, Geneva, Switzerland, February 10-13, 2003.

Doyle R and Stern S. Consideration of New Radiation Safety Standards for CT Equipment. A Diagnostic Imaging Conference on New Modalities and Radiation Safety (cosponsored by the Queen's University and the Hawaii Department of Health in partnership with the American College of Radiology). Honolulu, Hawaii, February 23, 2003

Drum B. Aberration Analyses Needed for FDA Evaluation of Safety and Effectiveness of Wavefront-Guided Refractive Surgical Devices. 4th International Congress of Wavefront Sensing and Aberration-Free Refractive Correction, San Francisco, CA. February 15, 2003.

Drum B, Hilmantel G, and Eydelman M. Evaluating the Safety and Effectiveness of "Aberration-Free" Refractive Surgery. Ninth FDA Science Forum, Washington, DC, April 24-25, 2003.

Drum B. FDA Regulation of Labeling and Promotional Claims in Marginally Effective Color Vision Devices. 17th Symposium of the International Color Vision Society, Seattle, WA, July 11-15, 2003.

Durfor CM. Challenges in Cell-based Therapeutics in Dermatology. Joint Meeting of Japanese Society for Investigative Dermatology, European Society for Dermatological Research Annual Meetings and Society for Investigative Dermatology, Miami, FL, May 1, 2003.

Foy JR. Common "Pitfalls" in Drug-Eluting Stent Applications. Cardiovascular Revascularization Therapy Conference, Washington, DC, January 29, 2003.

Foy JR. Drug-Device Combination Products: Device Perspective. 39th Annual Meeting of the Drug Information Association, San Antonio, TX, June 16, 2003.

Foy JR. Drug-Eluting Coronary Stents: A Case Study (Challenges & Outcomes). 39th Annual Meeting of the Drug Information Association, San Antonio, TX, June 17, 2003.

Foy JR. FDA's Top Ten List for Drug-Eluting Stents. Transcatheter Cardiovascular Therapeutics Conference, Washington, DC, September 18, 2003.

Gatling RR. Bundling Multiple Devices in a Single Application. AdvaMed's 13th Annual Device Submissions Workshop, Washington, DC, June 4, 2003.

Goode JL. Best Practices to Get an IDE Approved for a Peripheral Drug Eluting Stent. Cardiac Revascularization Therapy 2003, Washington DC, January 29, 2003.

Goode JL. Peripheral Drug Eluting Stents: Similarities To and Differences From Coronary Drug Eluting Stents. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Harvey ED. Preclinical and Clinical Testing of Peripheral Drug-Eluting Stents. FDA Town Hall Meeting, Cardiovascular Revascularization Therapies Annual Meeting, January 2003.

Harvey ED. Regulatory Considerations for Carotid Stent Trials. International Society of Endovascular Specialists 10th Annual Meeting, Phoenix, AZ, February 2003.

Harvey ED. Regulatory Considerations for Biliary versus vascular stents. Stent Summit, Cleveland Clinic, Cleveland, OH, September 11, 2003.

Harvey ED. Carotid Stenting: an FDA Overview. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Harvey ED. Peripheral Stenting: an FDA Overview. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Hawthorne CA. Using Regulations, Standards, and Guidance Documents to Strengthen Your Regulatory Strategy. Regulatory Affairs Professional Society (RAPS) Annual Conference, Washington, DC, October 2002.

Hilmantel G. FDA Post-Approval Clinical Studies of 30-Day Extended Wear Contact Lenses, American Academy of Optometry, San Diego, CA, December 2002.

Ho C and Kurtzman SB. Issues in Using Databases of Pre-Recorded Physiological Signals to Test Medical Devices, Rocky Mountain Bioengineering Symposium, Biloxi, MS, April 2003.

Hudson PL. CDRH Regulation of Tissue Engineered Products. 7th Annual Engineering Tissues Workshop, Hilton Head, SC, February 26 - March 1, 2003.

Kaiser AD. Science-based Testing for Combination Devices. The National Academies' Biomedical Engineering Materials and Applications (BEMA) Roundtable-"Science-based Assessment: Accelerating Product Development of Combination Medical Devices," Washington, DC, April 22-23, 2003

Kammula R. Use of International Standards in the Biocompatibility Evaluation of Medical Devices. American College of Toxicologists (annual meeting), Hershey, PA, October 10, 2002.

Kammula R. Convened and chaired the Working Group 9 (Effects on Blood) committee meeting at ISO TC 194, "Biological Evolution of Medical Devices," Alexandria, VA, April 7-11, 2003.

Mallis E. FDA Perspective on Novel Diagnostic Catheters. American College of Cardiology, Chicago, IL, March 29, 2003.

Malshet V. FDA Regulation of Cochlear Implants. Cochlear Implants Symposium at the First International Conference on Medical Implants, Bethesda, MD, July 27, 2003.

Mann E. Meningitis in Cochlear Implant Recipients. 2003 International Pediatric Cochlear Implant Meeting, Washington, DC, April 24, 2003.

Melkerson M. OSMA Orthopedic and Restorative Update. Alexandria, VA, October 25, 2002.

Melkerson M and Stevens T. OSMA Orthopedic and Restorative Update. Annapolis, MD, April 25, 2003.

Mitchell D. Clinical Investigator Responsibilities for Medical Device Investigations. Annual Clinical Investigator Conference sponsored by the Univ. of Washington, Seattle, WA, May 2003.

Morris J. CDRH's Current Regulatory Approach for Antimicrobial Coated Medical Devices as well as Combination Products, at the Center for Biofilm Engineering Technical Advisory Conference (TAC), Bozeman, MO, July 22-24, 2003.

Nguyen T. Modular and Expedited PMA Updates. Medical Device Alley, Minneapolis, MN, June 2003.

Nutter C. Participated in a Medical Packaging Roundtable teleconference discussion in London, England. October 2002. Highlights of the teleconference were published as an article entitled "Medical Packaging Roundtable: Standardizing a Global Approach to Packaging" (Harmonizing ISO 11607 and EN 868-1) in Pharmaceutical & Medical Packaging News, December 2002.

Nutter C. Requirements for Products Labeled 'STERILE' (focusing on SAL for terminally sterilized and contamination rate for aseptically processed products and addressing two standards: EN 556 and AAMI ST67). 13th Annual AAMI/FDA International Conference on Medical Device Standards and Regulation, Washington, DC, March 11-12, 2003.

Pinto H. Regulatory Considerations for Various CPR Devices, Palm Springs, CA, June 2003.

Pluhowski NJ. MDUFMA Pediatric Provisions and Advisory Panel Update. The 6th Annual FDA-OCRA Educational Conference--FDA & OCRA: Understanding The Changing Landscape, Irvine, CA, June 2003.

Pluhowski NJ. PMA Filing. The 6th Annual FDA-OCRA Educational Conference--FDA & OCRA: Understanding The Changing Landscape, Irvine, CA, June 2003.

Pollard C. Regulatory Considerations for Medical Device Development. Harvard-MIT Biomedical Enterprises Program, Boston, MA, April 2003.

Provost M. Regulatory Approaches for Biological/Device Combination Products. CDRH Drug Information Association Annual Meeting, San Antonio, TX, June 2003.

Provost M. CDRH Perspective on Regulation of Tissue Engineered Medical Products. Engineering Tissue Growth International Conference and Exposition, March 2003.

Rhodes SP. CDRH Perspective on the Regulation of Novel Wound Dressings. DARPA Wound Healing Workshop, Annapolis, MD, September 23, 2003.

Rhodes SP. Clinical Studies and Least Burdensome Issues. MassMedic, Boston, MA, March 28, 2003.

Romanell LJ. 510(k) MDUFMA Update. AdvaMed's 13th Annual Device Submissions Workshop, Washington, DC, June 4-5, 2003.

Rosecrans HS. Understanding When to Submit a 510(k) and the General vs. Specific Labeling Guidance. AdvaMed/MTLI Seminar, Alexandria, VA, February 2003.

Rosecrans HS. 510(k) Program Update. Regulatory Affairs Professional Society 2003 Medical Device Conference, San Francisco, CA, March 2003.

Rosecrans HS. 510(k) Program Update. 6th Annual FDA-Orange County Regulatory Affairs Education Conference, Irvine, CA, June 2003.

Rosenthal AR and Eydelman M. Regulation of Medical Devices. Annual Meeting of American Academy of Ophthalmology, Orlando, FL, October 2003.

Rosenthal AR. Promote FDA to Corporate Ophthalmology. American Academy of Ophthalmology - Corporate Advisory Council, San Francisco, CA, September 2003.

Saviola J. Color Additives in Medical Devices. FDA, Center for Food Safety and Applied Nutrition (CFSAN) Office of Food Additive Safety, Regulatory Grand Rounds, March 11, 2003.

Saviola J. Regulation of Contact Lenses. Association of Regulatory Boards of Optometry (ARBO) Annual Meeting, Contemporary Issues Symposium, San Diego, CA, June 2003.

Schultz D. FDA Regulation of Medical Devices: Today and Tomorrow. University of Colorado, Denver, CO, February 2003.

Schultz D. FDA Regulation of Medical Devices: Today and Tomorrow. St. Joseph Hospital, Denver, CO, February 2003.

Schultz D. FDA Regulation of Medical Devices: Today and Tomorrow. Laparoscopy Meeting, Vail, CO, February 2003.

Schultz D. General/Specific Revisited. AdvaMed, Washington, DC, February 2003.

Schultz D. The Medical Device Product Lifecycle; Is the Concept Worth Developing? DIA, San Francisco, CA, February 2003.

Schultz D. Workshop: Key Issues in Trial Design for Devices in Heart Failure. Heart Failure Society of America, Washington, DC, February 2003.

Schultz D. FDA Initiatives. Regulatory Affairs Professional Society (RAPS), San Francisco, CA, March 2003.

Schultz D. FDA Update. North American Society for Pacing and Electrophysiology (NASPE), Tysons Corner, VA, April 2003.

Schultz D. CDRH Update. Orange County Regulatory Affairs (OCRA), Irvine, CA, June 2003.

Schultz D. Safe and Effective/Reasonable and Necessary: A CDRH Perspective. Heart Failure Society of America, September 2003.

Schultz D. FDA's Perspective on Risk in Medical Devices. Regulatory Affairs Professional Society (RAPS), Baltimore, MD, October 2003.

Schultz D. The Changing World of Medical Devices. Wisconsin Biotechnology Association, Madison, WI, November 2003.

Shulman M. Introduction to 510(k) Submissions. Advanced Issues in Premarket Notification. Medical Design and Manufacturing (MD&M) West Conference, Anaheim, CA, February 2003.

Shulman M. Premarket Notification. AMDM In Vitro Diagnostics 510(k) Workshop, Rockville, MD, April 2003.

Shulman M. Introduction to 510(k) Submissions. Advanced Issued in Premarket Notification. Medical Design and Manufacturing (MD&M) East Conference, New York City, NY, June 2003.

Swain J. Women and Cardiovascular Device Trials". USC Symposium on Women and Cardiovascular Disease, Laguna Niguel, CA, June 2003.

Swain J. The FDA and Devices for Heart Failure. American Heart Association, San Diego Chapter, CA, April 4, 2003.

Swain J. Clinical Perspectives on Patient Selection and Endpoints for Heart Failure Trials. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Swain J. Clinical Trials for AMI Devices: Design, Endpoints, and Surrogate Markers. Transcatheter Cardiovascular Therapeutics, Washington, DC, September 18, 2003.

Swain J. Septal Defect and Left Atrial Appendage Closure Devices: Recent Experiences and Perspectives on Pathways for Regulatory Approval. Transcatheter Therapeutics meeting, Washington, DC, September 18, 2003.

Swain J. Percutaneous Valve Replacement and Implantable Devices for Valve Repair. Transcatheter Therapeutics meeting, Washington, DC, September 18, 2003.

Tillman DB. Modifications to PMA-approved devices: a view from the trenches, RAPS Annual Meeting, Washington, DC, October 2002.

Tillman DB. Overview of Issues Involving Pacing Device Approval for CHF Indications. Heart Failure Society of American Workshop - Trial Design for Heart Failure Devices, Rockville, MD, February 27, 2003

Tillman DB. The More the Merrier: DCD's experience with the Medical Device Fellowship Program. ASAIO Regulatory Workshop, Washington, DC, June 2003.

Tillman DB. Cardiovascular Device Update. AdvaMed Medical Device Submission Workshop, Rockville, MD, June 2003.

Warburton K. FDA Update. American National Standards Institute (ANSI) Committee Z80 for Ophthalmic Device Standards, Ft. Lauderdale, FL, March 2003.

Weitershausen J. FDA Clearance and Medical Device Issues - Oxygen Equipment. Oxygen Standardization Coordinating Group Annual Meeting, Davenport, IA, June 2003.

Whipple D. FDA Update. American National Standards Institute (ANSI) Committee Z80 for Ophthalmic Device Standards, Baltimore, MD, October 2002.

Witten CM. Regulation of Neurological Devices. A Conversation with Neurological Disease Patient Advocacy Organizations, Rockville, MD, April 24, 2003.

Witten CM. Plastic and Reconstructive Surgery Device Issues. FDA International Visitors from Ireland, Rockville, MD, May 14, 2003.

Witten CM. RHAIR. Society for Academic Emergency Medicine, Boston, MA, May 31, 2003.

Witten CM. DBS Viewed from FDA. DBS Consortium Meeting, Washington, DC, September 30, 2003.

Witten CM. Standards: Implementations by CDRH. ASTM Tissue Engineering Symposium, Miami, FL, November 5, 2002.

Wolanski N. PMA Update: Assessing User Fees and PMA Filing. Medical Device Alley, Minneapolis, MN, June 2003.

Zimmerman BA. FDA Regulation of Orthopedic Devices. Medical Implant Conference, Bethesda, MD, July 28, 2003.