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FY 2007 and 2006 ODE Annual Report - Appendix B - ODE Publications

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The following is a bibliography of articles and abstracts prepared by the ODE staff and published or presented during FY 2006 and FY 2007.

Journals, Newsletter Articles and Book Chapters

Abel DB and Smith AC. Providing a Reasonable Assurance of Safety and Effectiveness. Endovasc Today 4(10):75-76, October 2005. 

Abel DB, Smith AC, and Yoder DL. Medical Device Reporting. Endovasc Today 5(6):71-73, June 2006.

Abel DB and Smith AC. Standardized Objective Performance Criteria and Control Datasets. Endovasc Today 5(4):87-89, April 2006.

Ashar BS, Engleman D, Kaufman D, Marion J, Miranda D, and Rich S. FDA/MedSun Interested in Safety Issues in the Obese Patient Population. MedSun: Newsletter #16, July 2007.

Baker K. An Overview of Current Techniques for Tonsillectomy. ORL Head Neck Nursing 24(3):8-12, Summer 2006.

Buch B. FDA Device Approval: Things You Didn't learn in Medical School or Residency. Am J Orthop 36(8):407-412, August 2007.

Cavanaugh KJ. Evaluation of Renal Artery Stenting. Endovasc Today 5(9):105-107, September 2006.

Cavanaugh KJ, Paserchia L, Phurrough S, and Abel DB. Status and Future of Carotid Stenting: Who are the Players and What is at Stake? Vascular Disease Management 3(3):255-259, May/June 2006.

Chen E, Sapirstein W, Ahn C, Swain J, and Zuckerman B. FDA Perspective on Clinical Trial Design for Cardiovascular Devices. Annals of Thoracic Surgery 82(3):773-5, September 2006.

De Luca RJ. New Wheelchair Keeps People on the Move. Maturity Health Matter, Issue 2. 1-2, Spring 2006.

Drum B. Federal Regulation of Vision Enhancement Devices in Normal and Abnormal Vision. (Conference Proc., Developments in Vision Enhancement Technology and their Evaluation) J Modern Optics 53(9):1215-1228, 2006.

Drum B, Calogero D, and Rorer E. Assessment of Visual Performance in the Evaluation of New Medical Products. Drug Discovery Today: Technologies 4(2):55-61, 2007. 

Eydelman M. The FDA’s Role Regarding International Ophthalmic Devices. Eyeworld 10(11):15, November 2005.

Eydelman M. FDA Post-Approval Studies. Eyeworld 11(3):12-13, March 2006.

Eydelman M. Humanitarian Use Devices. Eyeworld 11(5):22, May 2006.

Eydelman M. Reporting of Medical Device-Related Adverse Events. Eyeworld 11(8):28-29, August 2006.

Eydelman MB, Drum B, Holladay J, Hilmantel G, Kezirian G, Durrie D, Stulting RD, Sanders D, and Wong B. Standardized Analyses of Correction of Astigmatism by Laser Systems that Reshape the Cornea. J Refract Surg 22(1):81-95, January/February 2006.

Eydelman MB, Drum B, Holladay J, Hilmantel G, Kezirian G, Durrie D, Stulting RD, Sanders D, and Wong B. Response to Alpins Letter to the Editor: Terms used for the Analysis of Astigmatism. J Refract Surg 22(6):528-529, June 2006.

Eydelman MB, Drum B, Holladay J, Hilmantel G, Kezirian G, Durrie D, Stulting RD, Sanders D, and Wong B. Response to Lenton Letter to the Editor: Standardized Analyses of Correction of Astigmatism by Laser Systems that Reshape the Cornea. J Refract Surg 22(7):638, September 2006.

Eydelman MB, Drum B, Holladay J, Hilmantel G, Kezirian G, Durrie D, Stulting RD, Sanders D, and Wong B. Response to Lenton Letter to the Editor: Standardized Analyses of Correction of Astigmatism. J Refract Surg 23(4):327-328, 2007.

Eydelman MB, Drum B, Holladay J, Hilmantel G, Kezirian G, Durrie D, Stulting RD, Sanders D, and Wong B. Response to Goggin Letter to the Editor: More on Astigmatism Analysis. J Refract Surg 23(5):430-431, 2007.

Faris OP and Shein M. Food and Drug Administration Perspective: Magnetic Resonance Imaging of Pacemaker and Implantable Cardioverter-Defibrillator Patients. Circulation 114(12):1232-3, September 19, 2006.

Ferriter A and Ashar BS. Radiofrequency Identification Technology: FDA Technical and Regulatory Perspective for Medical Devices. The Journal of Biolaw and Business 10(3):52-54, 2007.

Fiorentino RP and Uchida T. How You Can Prevent Poor Data. Endovasc Today 5(2):79-81, February 2006.

Goode J, Sapirstein W, and Zuckerman B. Editorial Comment: FDA Perspective on Clinical Trial Design for Femoropopliteal Stent Correction of Peripheral Vascular Insufficiency Cardiovascular Devices. Catheterization and Cardiovascular Interventions 69(6):920-1, May 1, 2007.

Graham J, Ahn C, Hai N, and Buch BD. Effect of Bone Density on Vertebral Strength and Stiffness After Percutaneous Vertebroplasty. Spine 32(18):E505-11, August 15, 2007.

Hampshire VA. Elements of a Good Animal Study. Endovasc Today 5(5):87-89, May 2006.

Hampshire V. Veterinarian Turns Relief Worker. Lab Animal (NY) 35(3):43, March 2006.

Mattamal GJ. U.S. FDA Perspective on Regulation of Cyanoacrylate Polymer Tissue Adhesives in Clinical Applications, Journal Materials Science Forum 539-543:692-697, 2007.

Michaud GY. The Role of Standards in the Development and Implementation of Clinical Laboratory Tests: a Domestic and Global Perspective. Cancer Biomark 1(4-5):209-216, 2005.

Mears D, Zimliki CL, and Chenault VM. Pancreatic β-Cells from Psammomys obesus, an Animal Model of Type 2 Diabetes, Display Diminished Sensitivity to Cholinergic Stimulation.Diabetes 55(Suppl 1):A370, June 2006.

Mears D, Zimliki CL, and Chenault VM. Electrical Signaling in Pancreatic β -cells from Psammomys Obesus, an Animal Model of Type 2 Diabetes: Implications for Glucose Homeostasis. Placenta 27(1):A38, January 2006.

Niparko JK, Leung J, Tucci DL, Burton MJ, and Mann EA. Cochlear Implants in Children: a Review of Reported Complications, Patterns of Device Failure, and Assessment of Current Approaches to Surveillance. In: Fields MJ, and Tilson HH, eds. Safe Medical Devices for Children, National Academic Press, pp. 382-421, 2006.

Peña C, Bowsher K, Costello A, De Luca R, Doll S, Li K, Schroeder M, and Stevens T. An Overview of FDA Medical Device Regulation as it Relates to Deep Brain Stimulation Devices. IEEE Transactions on Neural Systems and Rehabilitation Engineering 15(3):421-4, September 2007.

Rumm P. The Need for Strengthening National Public Health Preparedness and Response to CBR Agent Threats. In: Strengthening National Public Health Preparedness and Response to Chemical, Biological, and Radiological Agent Threats, Volume 20 NATO Security through Science Series: Human and Societal Dynamics, edited by C.E. Cummings and E. Stikova, IOS Press, June 2007, pages 20:3-7.

Rumm P and Cummings CE. Social Marketing as a Potentially Valuable Tool for Preparedness. In: Strengthening National Public Health Preparedness and Response to Chemical, Biological, and Radiological Agent Threat, Volume 20 NATO Security through Science Series: Human and Societal Dynamics, edited by C.E. Cummings and E. Stikova, IOS Press, June 2007, pages 165-167.

Runner S. FDA Marketing Claims and the Practitioner. In: Second Evidence Based Dentistry Conference. Chicago, Illinois. Sponsor Elsevier Publishing Co. November 5, 2005.

Samuels-Reid J, Bezabeh S, and Tavris DR. Selected Medical Devices used to Manage Diabetes Mellitus. In : Medical Device Epidemiology and Surveillance, John Wiley & Sons, pages 219-235 February 23, 2007.

Sapirstein W, Chen E, Swain J, and Zuckerman B. US FDA perspective on regulatory issues affecting circulatory assist devices. Expert Review of Medical Devices 3(6):749-53, November 2006.

Saviola JF. The Current FDA View on Overnight Orthokeratology: How We Got Here and Where We Are Going. Cornea 24(7):770-771, October 2005.

Seidman SJ, Ruggera PS, Brockman RG, Lewis B, and Shein MJ. Electromagnetic Compatibility of Pacemakers and Implantable Cardiac Defibrillators Exposed to RFID Readers. International Journal of Radio Frequency Identification Technology and Applications 1(3):237-6, 2007.

Smith AC and Abel DB. Regulation of Peripheral Vascular Devices. Endovasc Today 4(11):93-94, November 2005.

Thomas JA, Chakrabarti K, Kaczmarek RV, Maslennikov A, Mitchell CA, and Romanyukha A. Abstract. Optimization of Reading Conditions for Flat Panel Displays. J Digital Imaging 19(2):181-7, June 2006.

Tsaneva-Atanasova K, Zimliki CL, Bertram R, and Sherman A. Diffusion of Calcium and Metabolites in Pancreatic Islets: Killing Oscillations with a Pitchfork. Biophysical J 90(10):3434-46, May 15, 2006.

Vogel R, Saha A, Chakrabarti K, and Badano A. Evaluation of High-Resolution and Mobile Display Systems for Digital Radiology in Dark and Bright Environments using

Human and Computational Observers. Journal of the Society for Information Display 15(6):357-365, June 2007.

Zuckerman BD, Sapirstein W, and Swain JA. The FDA Role in the Development of Percutaneous Heart Valve Technology. EuroIntervention Supplements 1 (Supplement A):A75-A78, 2006.

Abstracts and Presentations

Abel D. The FDA Approval Process. 6th International Vascular and Endovascular Course (IVEC), Milan, Italy (via telephone) October 13, 2005.

Abel D. Great Debate I: Does Clinical Investigation Ownership/Payment Influence Outcome? We have concerns. International Symposium on Endovascular Therapy, Miami, FL, January 23, 2006.

Abel D. The Regulation of Thoracic vs. Abdominal Endografts. International Symposium on Endovascular Therapy, Miami, FL, January 25, 2006.

Abel D. Update: The Establishment of Control Data-Sets for AAA and Thoracic Endovascular Grafts. International Congress XIX, Endovascular Interventions, Scottsdale, AZ, February 13, 2006.

Abel D. The Regulation of Medical Devices: What You Should Know as Physicians. University of Pennsylvania Surgical Grand Rounds, Philadelphia, PA, March 2, 2006.

Abel D. Regulatory Update on FDA Approval of AAA and Thoracic Endografts. The 2nd Annual Penn Update on Aortic and Carotid Interventions, Philadelphia, PA, April 29, 2006.

Abel D. Cardiovascular Biomaterials: Overview of Current FDA Understanding. Biomedical Engineering Materials and Applications (BEMA), Rockville, MD, May 31, 2006.

Abel D. FDA Position on Registries and Trials. Vascular Annual Meeting, Philadelphia, PA, June 3, 2006.

Abel D. Moderator. Stent Summit, Cleveland, OH, August 24-26, 2006.

Abel D. The Risks and Benefits of Randomized Studies. 7th International Vascular and Endovascular Course (IVEC), Milan, Italy, October 15-17, 2006.

Abel D. Ethical Issues Surrounding Live Case Demonstrations: Who Benefits And Who Pays A Price? 33rd VEITH Symposium, New York, NY, November 18, 2006.

Abel D. "Comment for Clarity" during the premise, Randomized European EVAR Trials Have Only Created Havoc and Should Not Be Applied in Selecting Endovascular Treatment for Abdominal Aortic Aneurysms. International Congress XX, Endovascular Interventions, Scottsdale, AZ, February 13, 2007.

Abel D. Professional Leadership Workshop. Student Chapter of the Society for Biomaterials, Chicago, IL, April 18, 2007.

Adjodha M. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Anderson J. Regulatory Submissions for Biomaterials in Spinal Devices. Medical Design & Manufacturing Conference, Minneapolis, MN, November 1, 2005.

Baker KH. The Food and Drug Administration: An Overview of Medical Device Evaluation. 11th Annual Spring into Practice: New Trends in ORL Nursing. Greater Baltimore Medical Center, Baltimore, MD, March 2006.

Baker KH. Clinical Trials of Medical Devices. Society of Otolaryngology and Head and Neck Nurses, Baltimore, MD, March 31, 2006.

Beers ET. Reuse of Devices Employed. Phacoemulsification, Atlanta, GA, September 11, 2006.

Berman B. FDA's role in the regulation of ophthalmic devices. Joint Commission on Allied Health Personnel in Ophthalmology, Annual Continuing Education Program for Ophthalmic Medical Personnel in conjunction with the Annual Meeting of the Academy of Ophthalmology in Las Vegas, NV, November 14, 2006 .

Betz R. GHTF and Review Issues for Dental Devices. Dental Trade Association. Gaithersburg, MD, May 18, 2006.

Bezabeh S. Closing the Loop - a panel discussion. National Institute of Biomedical Imaging and Bioengineering, Bethesda, MD, December 19, 2005.

Blackwell A. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Boam A. Off-Label Use of Devices: FDA Perspective. ACC, Atlanta, GA, March 14, 2006.

Boam A. Discussant - FDA Workshop. CRT, Arlington, VA, April 4, 2006.

Boam A. Combination Products - Regulatory Challenges. FDA Science Forum, Washington, DC, April 18-19 2006.

Brockman R and Faris O. Implantable Monitoring Devices for Heart Failure: FDA Perspective. Heart Failure Society of America, Rockville, MD, March 30, 2006.

Brockman R. FDA Policy Update on Catheter Ablation of Atrial Fibrillation. Boston Atrial Fibrillation Symposium, Boston, MA, January 12, 2007.

Brockman R. Health Hazard Evaluation Workshop - What FDA Looks for in an HHE. AdvaMed Rockville, MD, April 30, 2007.

Brockman R. Heart Failure Monitors: Regulatory Implications. Heart Failure Society of America, Rockville, MD, June 1, 2007.

Brooks M. Requirements of Devices used for Power Injection of Contrast Media: Device Focus, Short-and Long-term Intravenous Catheter, Implanted Ports, Intravascular Administration Sets and Accessories. FDA Science Forum, Washington, DC, April 18, 2006.

Brown SA. Pre-Collaboration Meetings with FDA. ACRP/FDA Workshop, Minneapolis, MN, August 2006.

Brown SA. Pre-Collaboration Meetings with FDA. North Dakota State University IRB, Fargo, ND, September 2006.

Brown SA. Points To Consider in Ethically, Conducting Medical Clinical Trials. North Dakota State University IRB, Fargo, ND, September 2006.

Browne M. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Buch B. The Use of Bayesian Statistics in Device Clinical trials: The Clinical perspective. Society of Clinical Trials Meeting, Arlington, VA, May 25, 2006.

Buch B. FDA and Industry Challenges. AdvaMed Meeting Health Hazard Evaluation Workshop: performing HHE and its impact on Field Action Decisions, Pooks Hill, MD, April 30, 2007.

Buch B. Emerging Practices and Clinical Research Issues. American Association of Orthopaedic Surgeons, Fracture Repair Symposium, Miami, FL, April 26-28, 2007.

Buch B. Trends in Orthopaedic Research, Submitting your 510k, IDE/PMA submissions, Clinical Data Presentations, Quality System Regulations, Registrations & Listing. Korean FDA and KIHDI, Seoul, Korea, June 28, 2007.

Buch B. Orthopaedic Devices: The Marketplace and FDA, The American Orthopaedic Foot & Ankle Society, Toronto, Canada, July 13, 2007.

Byrd L. Practical Preparation of PMA. AdvaMed, Crystal City, VA, March 2006.

Byrd L. PMA Update. RAPS 2007 Horizons Conference & Exhibition, San Francisco, CA, March 30, 2007.

Calogero D. Update on Status of All ANSI and ISO Standards for Ophthalmic Implant Devices. International Club on Biomaterials and Regenerative Medicine in Ophthalmology, San Francisco, CA, March 17, 2006.

Calogero D. Intraocular Lenses: Overview of Preclinical Testing. National Academy of Sciences Biomedical Engineering Materials and Applications Meeting, Rockville, MD, May 31, 2006.

Cavanaugh K. Workshop on Medical Simulation (Radiology) – FDA Perspectives on Medical Simulation. International Meeting on Medical Simulation, San Diego, CA, January 15, 2006.

Cavanaugh K. FDA Perspective on Medical Simulation-Based Training for Cardiovascular Devices. Medicine Meets Virtual Reality, Long Beach, CA, January 24, 2006.

Cavanaugh K. Role of CDRH in the Review of Combined Catheter, Cell, and Gene Product Submissions. Genomics, Proteomics, and Cellular Therapies, Scottsdale, AZ, February 11, 2006.

Cavanaugh K. Carotid Stents: FDA Approval and Post-Approval Studies. Society for Cardiovascular Angiography and Imaging Core Curriculum in Carotid Stenting, Atlanta, GA, March 31, 2006.

Cavanaugh K. Training and Credentialing in Endovascular Interventions. TCT, Washington, DC, October 23, 2006.

Cavanaugh K. Current Status and Future Directions of Interventional Cardiovascular Simulation. TCT, Washington, DC, October 25, 2006.

Cavanaugh K. Convergence of PMA and Shonin Application Submissions: Opening Comments U.S. – Japan Harmonization by Doing. Think Tank West, Durham, NC, January 11, 2007.

Cavanaugh K. FDA Update on Carotid Stenting. International Symposium on Endovascular Therapies, Hollywood, FL, January 29, 2007.

Cavanaugh K. FDA Update on Carotid Embolic Protection Devices. International Symposium on Endovascular Therapies, Hollywood, FL, January 29, 2007.

Cavanaugh K. Embolic Protection in the Peripheral Circulation: What Clinical Data Are Needed? International Symposium on Endovascular Therapies Hollywood, FL, January 30, 2007.

Cavanaugh K. Differences in Optimizing Patient Selection and Evaluating Treatment Options. International Society of Endovascular Specialists Endovascular Congress, Scottsdale, AZ, February 15, 2007.

Cavanaugh K. PMAs, 510(k)s, and Advanced IDE Topics. Institutional Review Board Annual Educational Conference - Current IRB Challenges and Practical Solutions, New York, NY, April 24, 2007.

Cavanaugh K. FDA Perspective on Medical Simulation and Simulation-Based Training for Cardiovascular Devices. CompMed Symposium on Computer Simulation in Medicine, Montreal, Canada, May 16, 2007.

Cavanaugh K. Corrosion Testing of Intravascular Stents: FDA Perspective. American Society for Testing and Materials International Workshop on Metallic Corrosion of Small Implants, Norfolk, VA, May 22, 2007.

Cavanaugh K. Carotid Stents: Current Testing Methods and Standards. Cleveland Clinic Stent Summit, Cleveland, OH, August 30, 2007.

Chakrabarti K. Current CDRH Thinking on Approval of FFDM Output Devices. RSNA-Radiological Society of North America: NEMA session, Chicago, IL, November 2005.

Chakrabarti K. Beyond the Ivory Tower: Careers Outside Academia for Physics PhD. Department of Physics at the University of Chicago, Chicago, IL, November 2006.

Chakrabarti K. POSTER: Effect of Room setting on Object Detectability for Two Different AMLCD Displays. Annual Meeting of the American Association of Physicists in Medicine, Minneapolis, MN, July 22, 2007.

Chandeysson P and Goode J. Peripheral Interventions: The FDA View. 2006 CRT, Arlington, VA, April 4, 2006.

Chen E and Swain J. Use of Left Ventricular Assists Devices in Less-Sick Populations. Heart Failure Society of America, Rockville, MD, March 30, 2006.

Chen E. Post Market Evaluation of LVADS: FDA Perspective. Cardiovascular Revascularization Therapies (CRT) Arlington, VA, April 3, 2006.

Chen E. Clinical Trial Design for Mechanical Devices in Acute Heart Failure: FDA Perspective. Acute Heart Failure Syndromes, Washington, DC, April 9, 2006.

Chen E. INTERMACS: The FDA Perspective International Society of Heart & Lung Transplantation. INTERMACS Annual Meeting, San Francisco, CA, April 24, 2007.

Chen E. FDA’s Perspectives on Pediatric Cardiac Assist Devices. 3rd International Pediatric Mechanical Circulatory Support Systems and Pediatric Cardiopulmonary Perfusion Hershey, PA, May 18, 2007.

Colburn S. Requirements of Devices used for Power Injection of Contrast Media: Device Focus, Short-and Long-term Intravenous Catheter, Implanted Ports, Intravascular Administration Sets and Accessories. FDA Science Forum, Washington, DC, April 18, 2006.

Costello A. Device Trials: FDA Perspective, Deep Brain Stimulation for Epilepsy AED IV Meeting, Sunny Isles, FL, March 21, 2007.

Cox A. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Cunningham T. FDA Regulation of Surgical masks. National Institutes of Occupational and Safety Health meeting on “FDA/NIOSH N95 Masks,” Rockville, MD, March 14, 2006.

Dawisha S. Overview of the Patient Reported Outcome Measures Guidance. International Society for Quality of Life Research: Patient Reported Outcomes and FDA Regulatory Guidance Meeting, Washington, DC, June 28-29, 2006.

Drum B. The Evolution of the Optical Zone in Corneal Refractive Surgery. 8th International Congress of Wavefront Sensing and Optimized Refractive Corrections, Santa Fe, NM, February 25, 2007.

Drum B. Comparisons between Simulated Night Driving Performance and Clinical Tests of Visual Acuity, Glare and Contrast Sensitivity. Association for Research in Vision and Ophthalmology (ARVO), Ft. Lauderdale, FL, May 7, 2007.

Eloff B, Aguel F, Brockman R, Ewing L, Ho C, Lacy F, Lappalainen S, Lewis B, Mezu-Nwaba N, Reilly S, Shoemaker L, and Mallis E.  Transitioning Prescription Use Medical Devices to Over-The-Counter Use.  International Society of Computerized Electrocardiology (ISCE), Puerto Morales, Mexico, April 21-25, 2007.

Eydelman M. A Guide to Ophthalmic Device and Drug Evaluation. 2005 Annual meeting of the American Academy of Ophthalmology (AAO), Chicago, IL, October 16, 2005.

Eydelman M. FDA's Role in Ophthalmic Devices. 2005 Annual Meeting of the Joint Commission on Allied Health Personnel in Ophthalmology (JCAHPO), Chicago, IL, October 17, 2005.

Eydelman M. Dialogue with the FDA. American Society of Cataract and Refractive Surgeons Annual meeting, San Francisco, CA, March 21, 2006.

Eydelman M. Endotoxin Level requirements in ISO Ophthalmic Standards related to TASS. International Standards Organization Work Group 7, Baden, Switzerland, April 27, 2006.

Eydelman M. FDA and Ophthalmic Medical Devices . Women in Ophthalmology 2006 Summer Symposium (WIO), Montreal, Canada, August 21, 2006.

Farb A. The Pathology of Drug-Eluting Stents and Other Insights into the Regulatory Pathway of a New Stent. University of Colorado at Denver Health Sciences Center, Denver, CO, February 6, 2006.

Farb A. Cardiac Pathology Rounds. University of Colorado at Denver Health Sciences Center, Denver, CO, February 6, 2006.

Farb A. The Regulatory Path to Understanding Plaque Vulnerability and Imaging Device Development. Cardiovascular Intervention Society, Denver, CO, February 6, 2006.

Farb A. Stent Thrombosis is a Problem of DES? CRT, Arlington, VA, April 4, 2006.

Farb A. PFO Closure/Migraine - FDA View. CRT, Arlington, VA, April 4, 2006.

Farb A. DES Studies - FDA View. CRT, Arlington, VA, April 4, 2006.

Farb A. Pathologic Insights into Hypersensitivity, Thrombosis and Late Restenosis. CRT, Arlington, VA, April 6, 2006.

Farb A. Moderator: Drug Eluting Stents In-Depth. CRT, Arlington, VA, April 6, 2006.

Farb A. Extracellular Matrix Contraction: A Target for Stent Restenosis Prevention. ISACB 10th Biennial Meeting, La Jolla, CA, March 11, 2006.

Felten R. Medical Device Review Processes. University of California, Department of Dermatology Grand Rounds, Irvine, CA, August 9, 2006.

Felten R. Safety vs. Efficacy: Industry and the FDA. Is the Device Approval Process
Working? Controversies and Conversation in Cutaneous Laser and Cosmetic Surgery Meeting, Carlsbad, CA, August 13, 2006.

Felten R. Regulating Pathways for Review of Medical Devices. The 27 th Annual Conference of the American Society for Laser Medicine and Surgery, Grapevine, TX, April 13-14, 2007.

Felten R. What We Need from Each Other - Interactive Discussion.  The 27th Annual Conference of the American Society for Laser Medicine and Surgery. Grapevine, TX, April 13-14, 2007.

Felten R. Safety vs Efficacy: Industry and the FDA Are We Trending in the Right Direction. Advanced Symposium – Controversies and Conversations in Laser and Cosmetic Surgery, Lake George, NY, August 10-12, 2007.

Fiorentino R. Standardized Endpoints. HCRI/INDUSTRY/FDA Workshop, Washington, DC, March 29, 2006.

Fiorentino R. DSMB and Safety Reporting. CRT, Arlington, VA, April 3, 2006.

Fiorentino R. Bioabsorbable Stents. CRT, Arlington, VA, April 3, 2006.

Fleischer DJ. FDA Regulatory Considerations for Heart Failure Devices. Transcatheter Cardiovascular Therapeutics, Washington, DC, October 19, 2005.

Foy J. Top 10 Reasons Why FDA Requests Information for Orthopaedic 510(k)s, The Orthopedic Surgical Manufactures Association, Alexandria, VA, October 19, 2006.

Gantt G. Requirements of Devices used for Power Injection of Contrast Media: Device Focus, Short- and Long-term Intravenous Catheter, Implanted Ports, Intravascular Administration Sets and Accessories. FDA Science Forum, Washington, DC, April 18, 2006.

Gatling R. eCopies and E-Submissions at CDRH. AdvaMed Medical Technology Software Conference, Rockville, MD, November 8, 2006.

Gonzalez G. FDA Point of View: Regulation of Hemodialysis Equipment. National Association of Nephrology Technicians (NANT), Atlanta, GA, March 9, 2007.

Goode J. FDA Review Opinion:  Drug Eluting Stents in the Periphery “Why aren’t Trials Further Along?”  International Society of Endovascular Therapy, Miami, FL, January 24, 2006.

Goode J. FDA Reviewer Perspective: Peripheral Vascular Drug-Device Combination Products. International Congress XIX, Scottsdale, AZ, February 16, 2006.

Goode J. FDA Reviewer Opinion: Peripheral Vascular Stent Update - Why aren't there more Peripheral Vascular Stents on the US Market? International Society of Endovascular Therapy, Hollywood, FL, January 30, 2007.

Hampshire VA . AWEN GROUP; "The Devil’s in the Details." Symposium on Animal Refinements, Fort Lauderdale, FL, February 2006.

Hampshire VA . AWEN Training Disaster Preparedness in Animal Facilities. AWEN, Salem, MA, September 21, 2006.

Hampshire VA . The Veterinary Role in Cardiovascular Device Review. USPHS Annual Meeting, Cincinnati, OH, June 6, 2007.

Hampton D. Panel Participant – School and Career Choices. NIAID, NIH, Bethesda, MD, February 5, 2007.

Hartzell JD, Spooner K, Howard R, Wegner S, and Wortmann G.  Race and Mental Health Diagnosis Are Risk Factors for Highly Active Antiretroviral Therapy Failure in a Military Cohort Despite Equal Access to Care. J Acquir Immune Defic Syndr 44(4):411-6, April 1, 2007.

Harvey E. Clinical Trials of Medical Devices, DARPA - FDA Overview, Arlington, VA, October 2005.

Harvey E. Clinical Trials for Medical Devices. PRIM&R, Boston, MA, December 2005.

Harvey E. Regulatory Issues.  Clinical Trials Methodology Workshop, RSNA, Phoenix, AZ, January 2006.

Harvey E. Regulatory Considerations for Clinical Device Trials, Reed Exhibitions Medical Devices of Puerto Rico, San Juan, PR, February 2006.

Harvey E. IDEs: Overview of IDE Regulations, Gaining FDA Approval and Getting Started. RAPS, San Diego, CA, March 2006.

Harvey E. IDE regulations. Georgetown Univ., Washington, DC, April 2006.

Harvey E. Basic Elements and Special Circumstances in Device Research. ACRP, Phoenix, AZ, April 2006.

Harvey E. FDA Advanced Clinical BIMO Course, Rockville, MD, June 2006.

Harvey E. IDE Regulations. SoCRA, Boston, MA, June 2006.

Hillebrenner M. Electrical Devices in Acute Heart Failure. Acute Heart Failure Syndromes, Washington, DC, April 9, 2006.

Hillebrenner E. Safety Reporting in DES Trials. DCRI/INDUSTRY/FDA Workshop, Washington, DC, May 4, 2007.

Hilmantel G. Sample Size Statistics for Accommodative Clinical Studies. American National Standards Institute’s Accommodative IOL meeting, Baltimore, MD, August 28, 2006.

Ho C, Eloff B, Lacy L, Shoemaker L and Mallis E. Issues for ECG Devices with Pre-Installed Leads and Reduced Leads. International Society for Computerized Electrocardiology, Niagara-on-the-Lake Ontario, Canada, April 22-27, 2006.

Hudson P. Xenografts: Biomaterials, Clinical and Regulatory Issues, Orthopaedic Research Society, San Diego, CA, February 10-14, 2007.

Husband M. Current Closed Loop and Interoperability Efforts. U.S. Army Institute of Surgical Research, San Antonio, TX, November 7, 2006.

Husband M. Current Closed Loop: Lessons Learned. Artificial Pancreas Working Group, Rockville, MD, June 4, 2007.

Hutter J and Saviola JF. Silicone Hydrogel Contact Lens Groupings. 13th Symposium on the Material Science and Chemistry of Contact Lenses, New Orleans, LA, November 29-December 1, 2006.

Ilev IK, Faaland RW, Landry RJ, and Calogero D. Confocal Fiber-Optic Laser Method for Intraocular Lens Power Testing: A Novel and Simple Approach for Precise Testing of Clinical Intraocular Lens Samples. FDA Science Forum, Washington, DC, April 18 -20, 2006.

Isayeva I, Luu HD, DeFoe J, Patwardhan D, Chen A, Vorvolakos K, and Das SS. Synthesis and Characterization of an Iron-Crosslinked Hyaluronic Acid-based (FeHa) Adhesion Barrier. 2006 FDA Science Forum Poster Session, Washington, DC, April 2006.

Jean R. FDA Device Evaluation: Navigating a Path to Market. Johns Hopkins University, Baltimore, MD, October 12, 2006.

Kaiser A. From Your Lab to the Market: Understanding the Industrial Product Development Pathway - Pathways to the Commercial Market: Regulatory Requirements. Orthopedic Research Society 53rd Annual Meeting, San Diego, CA, February 13, 2007.

Kammula R. Historical Perspective on CDRH Regulated Devices. Office of Cellular, Tissue & Gene Therapies, CBER, Rockville, MD, October 2006.

Kane J. Patient Perceptions Leading to Explantation (Cochlear Implants). NIST and Device Manufacturing Industry, Gaithersburg, MD, October 3, 2006.

Kane J and Regnault WF. Analysis of the Loss of Hermeticity and Its Potential Effects on the Performance of Cochlear Implants; and Overview of U.S. Food & Drug Administration Data Related to “Hard” and “Soft” Cochlear Implant Failures. Fifth International Symposium: Objective Measures in Cochlear and Brainstem Implants, Varese, Italy, May 9-12, 2007.

Kang SA. Clinical Trials for Hepatocellular Carcinoma (HCC) FDA Perspective. 9th World Congress of Nuclear Medicine and Biology (WCNMB), Seoul, Korea, October 2006.

Kurtzman S. Surrogate Endpoints for Studies of Non-Stent Treatments for Acute ST-Elevation MI. CRT, Arlington, VA, April 4, 2006.

Landry RJ, Ilev IK, Pfefer TJ, Faaland RW, and Calogero D. Characterizing Reflections from Intraocular Lens Implants. FDA Science Forum, Washington DC, April 18 -20, 2006.

Lappalainen SK , Gomatam SV, and Hitchins VM. Poster: Residual Protein & Total Organic Carbon Residues on GI Biopsy Forceps. FDA Science Forum, Washington , DC , April 18-19, 2006.

Lappalainen SK , Gomatam SV, and Hitchins VM. Poster: Residual Protein & Total Organic Carbon Residues on EP Catheters. FDA Science Forum, Washington, DC, April 18-19, 2006.

Lin C. Regulation of Combination Products. 2005 APEC Regulatory Science Symposium. Taipei, Taiwan. Sponsor Bureau of Pharmaceutical Affairs, Department of Health, Taiwan, November 14-18, 2005. Dr. Lin also moderated the session.

Lin C. FDA Regulation of Surgical Masks and Respirators. Institute of Medicine National Academy of Sciences Committee on the Development of Reusable Facemasks for Use during an Influenza Pandemic, Washington, DC, January 23, 2006.

Lin C. Special Training Required for Evaluators. International Briefing on the Regulation of Single Use Devices, Rockville, MD, March 16, 2006.

Lin C. Facilitating Medical Device Technology and Innovation: An FDA Perspective. Forty-fifth Annual Conference of Japanese Society for Medical and Biological Engineering, Tokyo, Japan, May 15, 2006.

Lin C. The United States Regulatory Initiatives in the Review of Medical Devices. Chinese Academy of Science and Chinese Stat FDA. China Forum on Medical Devices, Suzhou, China, June 10, 2006.

Lin C. The 510(k) Review Process: Emphasis on Sterilization. CBER Educational Conference. Rockville, MD, January 16, 2007.

Lin C. Antimicrobial Medical Devices: Regulatory Perspective. Center for Biofilm Engineering, Montana State University, Bozeman, MN, February 8, 2007.

Lipman J. Requirements of Devices used for Power Injection of Contrast Media: Device Focus, Short-and Long-term Intravenous Catheter, Implanted Ports, Intravascular Administration Sets and Accessories. FDA Science Forum, Washington, DC, April 18, 2006.

Lucas A, Wray-Cohen D, Lappalainen SK, and Brown R. Poster: Mild Hyperthermic Incubation Can Potentiate the Cytotoxicity of Exogenous Compounds on Medical Devices. FDA Science Forum, Washington, DC, April 18-19 2006.

Malshet V. Local Lymph Node Assay. International Standards Organization (ISO) 10993 Biological Evaluation of Medical Devices Annual Meeting, the Irritation and Sensitization Session, Jeju Island, Korea, September 28-October 5, 2007.

Mattamal G. U.S. FDA Perspective on the Regulations of Cyanoacrylate Polymer Tissue Adhesives in Clinical Applications. American Institute of Chemical Engineers, Cincinnati, OH, November 1, 2005.

Mattamal G. U.S. FDA Perspective on the Regulations of Cyanoacrylate Polymer Tissue Adhesives in Clinical Applications. 5 th International Conference on Advanced Materials and Biomaterials Symposium, Vancouver, Canada, July 6, 2006.

Mattamal G. U.S. FDA Perspective on the Regulations of Cyanoacrylate Polymer Tissue Adhesives in Clinical Applications. Institute of Biomedical Engineering National Taiwan University, Taipei, Taiwan, December 16, 2006.

Mattamal G. U.S. FDA Perspective on the Regulations of Medical Grade Polymers, in particular the Cyanoacrylate Polymer Tissue Adhesives in Clinical Applications. Medical Grade Polymers 2007 International Symposium on Biomedical Polymers, Philadelphia, PA, September 12-13, 2007.

Mayhall E. List of Technical Requirements. International Briefing on the Regulation of Single Use Devices, Rockville, MD, March 16, 2006.

Mayhall E. Validation Evidence Required. International Briefing on the Regulation of Single Use Devices, Rockville, MD, March 16, 2006.

Mayhall E. Validation Review of Single Use Devices (SUDs): Criteria for Cleaning Validation. Chinese State Food and Drug Administration, Rockville, MD, April 13, 2007.

Melkerson M. Initiatives & Perspectives, FDA Involvement in the Development and Use of Standards. Georgia Tech Student Event, Atlanta, GA, November 16, 2006.

Melkerson M. Pathways from Ideas or Lab to the Market: Regulation of Tissue Engineering and Regenerative Medicine Products: Boost the Budget – Invest in Medical and Biological Engineering. American Institute for Medical and Biological Engineering’s 2 nd Annual Federal Symposium, Washington, DC, September 10, 2007.

Mezu-Nwaba N. Participated in the “Ask the Professional Forum” and Organized Pharmacists Volunteers from the FDA for the Heart Health Symposium sponsored by the Montgomery County Health Department for the “Glorifying Our Spiritual and Physical Existence for Life (GOSPEL) Program,” at the Hilton Hotel, Gaithersburg, MD, April 1, 2006.

Mezu-Nwaba N. Improving Quality of Care in Sickle Cell Patients: Key to Managing an Otherwise Painful Disease. FDA Science Forum, Washington, DC, April 18-19, 2006.

Mezu-Nwaba N. “PHARMACY" A Prescription for a Rewarding Career. Ridgeview Middle School, Rockville, MD, May 12, 2006.

Mezu-Nwaba N. Improving Quality of Care in Sickle Cell Patients: Key to Managing an Otherwise Painful Disease. The Sickle Cell Disease Association’s 34th Annual Convention, Dallas, TX, September 25-28, 2006.

Mezu-Nwaba N. Improving Quality of Care in Sickle Cell Patients: Key to Managing an Otherwise Painful Disease. The Sickle Cell Disease Association’s Career Day Presentation at St Louis School “Careers in the United States Public Health Service,” Clarksville, MD, May 22, 2007.

Mezu-Nwaba N. Participant, Ask the Professional Forum” and Organized Pharmacists Volunteers from the FDA for the Heart Health Symposium sponsored by the Montgomery County Health Department for the “Glorifying Our Spiritual and Physical Existence for Life (GOSPEL) Program, at Suburban Hospital, Bethesda, MD, June, 2007.

Michaud G. Study Group 1 Update. GHTF Study Group 1. Global Harmonization Task Force Steering Committee, London, England, November 9, 2005.

Michaud G. Going Global with GHTF: Global Harmonization Task Force Study Group. Clinivation Web Cast, January 26, 2006.

Michaud G. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Michaud G. Reprocessed Single-Use Devices: Risk Stratification and Premarket Oversight. International Briefing on the Regulation of Single Use Devices, Rockville, MD, March 16, 2006.

Michaud G. FDA Premarket Oversight of Reprocessed Single-Use Devices. Roadmap to Patient Safety Series: Reuse of Single-use Devices - Is It Right for Your Hospital? ECRI Audio Conference, September 21, 2006.

Michaud G. The FDA Regulation of Personal Protective Equipment. Pandemic and Seasonal Risk Management Committee, Washington, DC, October 4, 2006.

Michaud G. The Regulation of Masks & N95 Respirators: Possible Mask and Respirator Use Under an EUA. DHHS Emergency Use Authorization Working Group, Washington, DC, November 9, 2006.

Michaud G. Global Harmonization Task Force Study Group 1 Update. Global Harmonization Meeting, Brussels, Belgium, November 29, 2006.

Michaud G. Reprocessed Single Use Devices: Risk Stratification and Premarket Oversight. Chinese State Food and Drug Administration, Rockville, MD, April 13, 2007.

Michaud G. Study Group 1 Update. Global Harmonization Task Force (GHTF) Steering Committee, Los Angeles, CA, May 8, 2007.

Michaud G. The Role of FDA in the Regulation of Masks/respirators and Facilitating the Availability of Adequate Device Supplies. Flu Risk Management Meeting, Washington, DC, September 21, 2007.

Morris J. Perspectives from the Food and Drug Administration. Innovative Solutions for Cancer Care: Image-Guided, Minimally Invasive Diagnosis and Treatment of Prostate Cancer, Washington, DC, October 2005.

Morris J. Review Criteria for Medical Devices that Use Antimicrobial Agents. Center for Prosthesis Infections (CPI)/Multidisciplinary Alliance Against Device Related Infections (MADRI), San Antonio, TX, August 2006.

Morris J. Oncology Image Guided Interventions: Opportunities for Collaboration. Seventh National Forum on Biomedical Imaging in Oncology, Bethesda, MD, February 2007.

Morris J. Medical Regulation. American Urogynecologic Society, Hollywood, FL, September 29, 2007.

Morris J. Adding Antimicrobial Agents to Medical Devices: A Case Study. 7 th Multidisciplinary Alliance Against Device-Related Infections Center for Prosthesis Infections (CPI)/Multidisciplinary Approach for Device Related Infections (MADRI), Broomfield, CO, August 10-12, 2007, and San Antonio, TX, August 3-6, 2007.

Morris J. Bringing Medical Devices from Research to Clinical Practice. Midwest Biomedical Engineering Conference at Case Western, Cleveland, OH, February 2007.

Moynahan M. Current and Future Role of Remote Monitoring in Postmarket Surveillance. Heart Rhythm Society annual meeting, Denver, CO, May 9, 2007

Mulry K. FDA Dental Activities. American Dental Association Council on Scientific Affairs, Chicago, IL, April 20, 2006.

Mulry K. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Murphey S. FDA Liaison Report. Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention, Atlanta, GA, February 10, 2006.

Murphey S. TSE Transmission by Surgical Instruments: Evaluation of Products Proposing to Reduce that Risk. Tenth International Transmissible Spongiform Encephalopathies meetings, Baltimore, MD, March 9, 2006.

Murphey S. Sterilization Standards: Upcoming Changes in the Approach to Medical Device Sterilization. Sixteenth Annual AAMI/FDA International Conference on Medical Device Standards and Regulations, Reston, VA, March 22, 2006.

Murphey S. Orchestrating the Goal of Preventing Device-Related Infections at the Medical Advances, Surgical Interventions and Regulatory Perspectives on Device-Related Infections. Center for Prosthesis Infection (CPI) and the Multidisciplinary Alliance Against Device-Related Infections (MADRI), San Antonio, TX, August 5, 2006.

Murphey S. Regulation of Personal Protective Equipment. Institute of Medicine, Washington, DC, October 23, 2006.

Murphey S. FDA Interactive Session-Case Study (on a device with added antimicrobial agent). 7th Annual Conference of the Center for Prosthesis Infection (CPI) and the Multidisciplinary Alliance Against Device Related Infections (MADRI), Broomfield, CO, August 11, 2007.

Nandkumar S. Bringing Otologic Devices to the U.S. Market. NIDCD, NIH Workshop, Bethesda, MD, May 9, 2007.

Nguyen T. MDUFMA- What it Means in 2005. RAPS, Baltimore, MD, March 2006.

Nguyen T. PMA Annual Reports. AdvaMed, Baltimore, MD, March 2006.

Nguyen T. Update on PMA Program. OCRA, Newport Beach, CA, May 2006.

Nguyen T. Premarket Approval. RAPS, Audio Conference, May 2006.

Nipper J. Premarket Submissions for Software: Special 510(k) Considerations.

AdvaMed Medical Technology Software Conference, Rockville, MD, November 8, 2006.

Nutter C. Sterile Barrier Systems. ASTM International Sterilization, Packaging, Manufacturer Council (SPMC) Packaging Sub-Committee, Dallas, TX, October 2005.

Nutter C. Webinar: Sterility Assurance Levels for Medical Products. Association for the Advancement of Medical Instrumentation, Arlington, VA, February 2006.

O'Callaghan K. VAD Use in Women: More Than Just a Sizing Issue? THINK TANK for Cardiovascular Research in Women, Bethesda, MD, February 17, 2006.

O'Callaghan K. Endpoints for Mechanical Devices in Acute Heart Failure. Acute Heart Failure Syndromes, Washington, DC, April 9, 2006.

O'Callaghan K. FDA’s Current Perspective: Clinical Trial Design for Pediatric Circulatory Support Devices. NHLBI Pediatric VAD Contractors' Meeting, Bethesda, MD, January 18, 2007.

Ogden N. Computer Assisted Surgery: Device Regulation. Johns Hopkins Medical School, Baltimore, MD, December 8, 2005.

Ogden N. U.S. FDA Computational Modeling and Computer Assisted Simulators/Trainers in Premarket Review of Devices. Telemedicine & Advanced Technology Research Center Annual Advance Medical Technology Review. Long Beach, CA, February 6, 2007.

Ogden N. Device Approval for Acute Ischemic Stroke: Beyond the MERCI Device. American Heart Association International Stroke Conference, San Francisco, CA, February 8, 2007.

Paquerault S, Petrick N, Myers KJ, Saha A, Samuelson F, Badano AB, and Gallas BD. Comparison of Concurrent-use CAD to CAD as a Second Reader in Mammographic Image Review. 92nd Annual Radiological Society of North America, Chicago, IL, November 26-December 1, 2006.

Pena C. Regulatory Perspective on Medical Devices for Children. NIH/National Institute of Child Health & Development, Washington, DC, October 5, 2005.

Pena C. Pre-Clinical and Clinical Considerations for Neuroprosthetic Devices. Department of Defense, Marina Del Rey, CA, October 10, 2005.

Pena C. Device Therapies: Approvals Beyond MERCI. Stroke Treatment Academic Industry Roundtable Conference, Arlington, VA, May 25, 2006.

Pereira A. Snoring and Sleep Apnea. Society of Otolaryngology and Head and Neck Nurses, Baltimore, MD, March 21, 2006.

Phillips R. Panel discussion - FDA Pre-Market Regulatory Process: Applications to Technologies for Radiation Biodosimetry After a Large-Scale, Radiological Incident. CMCR Workshop, Bethesda, MD, March 27, 2006.

Phillips R. Patient Safety Measures. Imaging in Medicine Course through Johns Hopkins University, Shady Grove, MD, May 2006.

Pinto P. Challenges with Dual Drugs on DES Platforms; New Drugs and New Polymers: CDRH Perspective. CRT 2007, Washington, DC, March 7, 2007.

Pinto H. PMA Submissions Workshop - During Submission Review. AdvaMed, Washington, DC, July 26, 2007.

Pollard C. Regulatory Overview. Harvard-MIT Biomedical Enterprise Program, Cambridge, MA, November 2005.

Pollard C. Regulatory Overview on Medical Device Development. Harvard-MIT Biomedical Enterprise Program, Cambridge, MA, November 14, 2006.

Pollard C. Premarket/Postmarket. Central Atlantic States Association of Food and Drug Officials (CASA), Colonial Heights, VA, January 30, 2007.

Rhodes S. Clinical Trials of Medical Devices.  US-Singapore HSE Meeting, Rockville, MD, June 13, 2007.

Rhodes S. Investigational Device Exemptions.  US- China JCCT Medical Task Force, Washington, DC, April 11, 2007.

Romanell L. 513(g)s - Requests for Information. AdvaMed, Washington D.C., November 2005.

Romanell L. 513(g)s - Requests for Information. AdvaMed, Arlington, VA, March 2006.

Romanell L. 513(g)s - Requests for Information. AdvaMed, San Francisco, CA, July 2006.

Romanell L. Speaker and Moderator, 510(k) 101 Course. AdvaMed, Las Vegas, NV, February 26-27, 2007.

Romanell L. Speaker and Moderator, 510(k) 101 Course. AdvaMed, Washington, DC, July 17-18, 2007.

Rorer E, Calogero D, and Drum B. Critical Path Initiative: Comparisons between Simulated Night Driving Performance and Clinical Tests of Visual Acuity, Glare and Contrast Sensitivity. FDA Science Forum, Washington, DC, 2006. April 18 -20, 2006.

Rosecrans H. Principles of Classification. ACRP, Phoenix, AZ, April 2006.

Rosecrans H. 510(k) Update, IVD Workshop. Rockville, MD, April 2006.

Rosecrans H. 510(k) update & de Novo. OCRA, Newport Beach, CA, May 2006.

Rosecrans H. 510(k) update & de Novo. SoCRA, Boston, MA, June 2006.

Rosecrans H. 510(k) update & de Novo. MD&M East, New York, NY, June 2006.

Rosecrans H. 510(k) Training. AdvaMed, San Francisco, CA, July 2006.

Rosecrans H. 510(k) Process Review Considerations. MDMA, San Diego, CA September 2006.

Rosecrans H. What FDA Looks for in a Submission. IBA, Salt Lake City, UT, September 2006.

Rumm P. Avian Flu: A Global Perspective. The Collage of Physicians of Philadelphia & the Global Interdependence Center, Philadelphia, PA, September 28, 2006.

Rumm P. Risk Management in the Home and Home Health Care, FDA/University of Houston Conference on Home Health, Houston, TX, September 17-18, 2007.

Runner S. FDA Marketing Claims and the Practitioner. Second Evidence Based Dentistry Conference, Chicago, IL, November 5, 2005.

Runner S. FDA Regulatory Practices. Annual Conference of the American Association of Dental Research, Orlando, FL, March 10, 2006.

Runner S. Regulation of Dental Devices. Fourth Year Dental Students. University of Illinois, Chicago, IL, April 13, 2007.

Runner S. Regulation of Dental Devices. Dental School Faculty, University of Illinois, Chicago, IL, April 13, 2007.

Runner S. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Samuels-Reid J. FDA and Industry Challenges: Dealing with Uncertainty. AdvaMed Health Hazard Evaluation Workshop, Section on Performing HHE and Its Impact on Field Action Decisions, Bethesda, MD, April 30, 2007.

Sapirstein W. Evolving Strategies for the Treatment of Valvular Heart Disease. FDA perspective. Dartmouth Device Development Symposium, Woodstock, VT, October 2006.

Saviola J. A Multi-State Outbreak of Fusarium Keratitis Linked to Contact Lens Solution Use: a Rapid Assessment of a Complex Problem. CDC Tuesday Morning Epidemiology Seminar - Guest Discussant, Atlanta, GA, June 13 2006.

Saviola J. Retinal Prostheses - Future Possibilities & Current Realities. American Academy of Optometry, Denver, CO, December 7-10, 2006.

Saviola J. Contact Lens Safety and the FDA: 1976 – 2007. International Contact Lens Leadership Summit, Ft. Lauderdale, FL, Mary 4-5, 2007.

Saylor DM, McDermott MK, Dair BJ, Toy J, Patwardhan DV, and Warren JA. Effect of Materials Selection in Controlled Drug Delivery Systems: (Bio) Degradable v. Non-Degradable Polymers. FDA Science Forum, Washington DC, April 18-20, 2006.

Saylor DM, McDermott MK, Dair BJ, Kim CA, Toy J, Patwardhan DV, and Warren JA.  Micro Structure Development and Release Behavior in Controlled Drug Delivery Systems. FDA Science Forum, Washington DC, April 18-20, 2006.

Schmidt J. List of Technical Requirements. International Briefing on the Regulation of Single Use Devices, Rockville, MD, March 16, 2006.

Schmidt J. Validation Evidence Required. International Briefing on the Regulation of Single Use Devices, Rockville, MD, March 16, 2006.

Schmidt J. Validation Review of Single Use Devices (SUDs): Sterilization Validation and Unique SUD Issues. Chinese State Food and Drug Administration, Rockville, MD, April 13, 2007.

Seidman SJ, Ruggera P, Brockman RG, Lewis BE, and Shein MJ. Electromagnetic Compatibility of Active Implantable Cardiac Devices Exposed to RFID Readers. 5 th RFID Academic Convocation, Orlando, FL, April 30, 2007.

Shein MJ. My Device May Be Defective – When Does FDA React. 27 th Annual Scientific Sessions of the Heart Rhythm Society, Boston, MA, May 2006.

Shein MJ. RFID and Active Implantable Cardiac Rhythm Management Devices Electromagnetic Compatibility. ISO RFID Working Group JTC/SC31/WG4, Arlington, VA, March 27, 2007.

Shih M and Saviola J. Collective Risk Management for a Sight-threatening Risk from the Expansion of Intraocular Gas Bubble at Various Stages of Perfluoropropane Intraocular Gas Device Life Cycle. FDA Science Forum, Washington, DC, April 20-21 2006.

Shoback B. CDRH Clinical Review of Premarket Approval Applications. Interagency Oncology Task Force (IOTF), Rockville, MD, June 2006.

Shulman M. 510(k) 101 Training. AdvaMed, Arlington, VA, March 2006.

Shulman M. Reclassification Petitions. ACRP, Phoenix, AZ, April 2006.

Shulman M. FDA Clearance or Approval. MD&M East, New York, NY, June 2006.

Shulman M. FDA Clearance or Approval. MD&M West, Anaheim, CA, July 2006.

Shulman M. 510(k) 101 Training. AdvaMed, San Francisco, CA July 2006.

Shulman M. 510(k) Procedures and PMA Procedures. Canadian Embassy, Toronto, Ottawa and Montreal, Canada September 2006.

Shulman M. FDA Clearance or Approval. MD&M West 2007, Anaheim, CA, February 2007.

Shulman M. FDA Clearance or Approval. MD&M East 2007, New York City, NY, June 2007.

Steen A. GHTF and Review Issues for Dental Devices. Dental Trade Association, Gaithersburg, MD, May 18, 2006.

Stevens T. DGRND Update – Orthopedic Spine Devices, The Orthopedic Surgical Manufactures Association, Washington, DC, October 20, 2006.

Stevens T. Emerging Practices and Clinical Research Issues, American Association of Orthopaedic Surgeons, Fracture Repair Symposium, Miami, FL, April 26-28, 2007.

Swain JA. How to Design Clinical Trials: Lessons Learned. New Era Cardiac Surgery Symposium, Newport Beach, CA, January 6, 2006.

Swain JA. Historical Controls and Non-Randomized Registries in Heart Valves:  FDA View.  CRT, Arlington, VA, April 4, 2006.

Swain JA. Percutaneous Valves:  FDA View.  CRT, Arlington, VA, April 4, 2006.

Thomas JA, Chakrabarti K, Kaczmarek RV, Mitchell C, Romanyukha A, Nemmers S, and Loscocco M. Poster session: Comparison of the Effects of Viewing Conditions and Viewing Angle on Objects Detectability for Different AMLCD Displays. American Association of Physicists in Medicine, 48th Annual Meeting, Orlando, FL, July-August 2006.

Tillman DB. The Regulatory Challenges of Combination Products. Design of Medical Devices Conference, April 2006.

Tillman DB. Medical Device Lifecycles: The Myth of ‘Premarket.’ AAMI Annual Conference, June 2006.

Tillman DB. Device Classification: A Brief Guide for the Perplexed. Dartmouth Drug Device Symposium, October 2006.

Tillman DB. Off-Label Use and Evidence-Based Medicine. TransCatheter Therapeutics (TCT), October 2006.

Tillman DB. The Regulation of Software: An Overview, AdvaMed Medical Technology Software Conference, November 2006.

Turtil S. Let’s Talk About Everything You Wanted to Know and Hot Topics: Updated 510(k) Sterility Review Guidance K90-1” Memo. International Association Healthcare Central Service Material Management (IAHCSMM), Las Vegas, NV, May 24, 2006.

Turtil S. Sterile Devices in Premarket Notification [510(k)] Submissions. CBER Educational Conference, Rockville, MD, January 16, 2007.

Turtil S. Establishing Package Integrity and Package Expiration. CBER Educational Conference, Rockville, Maryland, January 16, 2007.

Turtil S. Validation Review of Single Use Devices (SUDs): Criteria for Cleaning Validation: Elements of Cleaning Process Validations and Test Protocols. Chinese State Food and Drug Administration, Rockville, MD, April 13, 2007.

Turtil S. AAMI/ANSI /ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices AAMI Standards Working Group, Arlington, VA, July 23, 2007.

Uchida T. Premarket Evaluation of DES-FDA View. CRT, Arlington, VA, April 3, 2006.

Uchida T. Adaptive Trial Design-FDA View. CRT, Arlington, VA, April 4, 2006.

Vaughan C. Percutaneous Valves: FDA View – Preclinical. CRT, Arlington, VA, April 4, 2006.

Vorvolakos K. Physical Properties of Abdominal Adhesion Barriers. 2006 FDA Science Forum Poster Session, Washington, DC, April 2006.

Warburton K. Poster - Absorption of Alexidine by Contact Lenses and Lens Cases and its Effect on Disinfection Activity against Fusarium Solani. American Society for Microbiology general meeting, Toronto, Canada, May 21-25, 2007.

Watson A. Closing the Loop as part of a panel discussion. National Institute of Biomedical Imaging and Bioengineering, Bethesda, MD, December 19, 2005.

Watson A. Regulation of Point-of-Care (POC) Medical Devices. NIH/National Institute of Biomedical Imaging and Bioengineering, Bethesda, MD, April 12, 2006.

Watson A. Pre-filled Syringes and Combination Products: A Medical Device Perspective. Prefilled Drug Association, Bethesda, MD, October 23, 2006.

Watson A. Regulatory Context for Electronic Health Records. AdvaMed. Washington, DC, November 8, 2006.

Wood G. CDRH Advisory Panel Review. Regulatory Affairs Professional Society (RAPS) Webcast, May 23, 2007.

Yen D. Surgical robots and MRI safety from a regulatory perspective. Institute of Electrical & Electronic Engineers International Congress on Robotica & Automation, Orlando, FL, May 15, 2006.

Yen D. Points to Consider for Marketing of Computerized and Robotic Surgical Systems in the U.S. 20 th International Congress on Computer Assisted Radiology & Surgery, Osaka, Japan, June 29, 2006.

Yen D. Regulating Medical Devices in the US: FDA Perspective. Surgical Grand Rounds at the Cleveland Clinic, Cleveland, OH, April 18, 2007.

Zimliki CL, Mears D, and Chenault VM. Glucose Sensing in Psammomys Obesus (Fat Sand Rat): Method for Converting Islets into Diabetic State. FDA Science Forum, Washington, DC, April 2006.

Zimliki C. The Physiology of Interstitial Fluids. Diabetes Technology Meeting, Atlanta, GA, November 4, 2006.

Zuckerman B. Moderator for HHS Town Hall TCT, Washington, DC, October 16, 2005.

Zuckerman B. Harmonization of Device Trials. Harmonization By Doing Symposium, Tokyo, Japan, December, 2005.

Zuckerman B. FDA and CV Development. Society of Thoracic Surgeons, Chicago, IL, January 27, 2006.

Zuckerman B. ICD Safety: Current FDA Perspective. Annual Scientific Session of the American College of Cardiology, Atlanta, GA, March 10, 2006.

Zuckerman B. Medical Device Development. CRT, Arlington, VA, April 4, 2006.

Zuckerman B. Percutaneous Heart Valve Development: FDA Perspective. Annual Symposium on New Interventions in Transcatheter Valve Techniques, San Francisco, CA, April 26, 2006.

Staff College Presenters and Faculty – FY 06 and FY 07

Boam, Ashley
Brown, Sheila
Ciarkowski, Art
Chakrabarti, Kish
Cotterell, Alison
Gatling, Robert
Gonzalez, Gema
Good, John
Hawthorn, Anne
Ho, Charles
Horbowyj, Roxolana
Husband, Michael
Jensen, D. Nick
Kammula, Raju
Less, Joanne
Lewis, Brian
Lin, Chiu
Mallis, Elias
Mann, Eric
Michaud, Ginette
Morris, Janine
Murphey, Sheila
Neuland, Carolyn
Nipper, Joshua
Nguyen, Thinh
Norfleet, William
Pena, Carlos
Provost, Miriam
Rechen, Eric
Rosecrans, Heather
Runner, Susan
Sacks, William
Samuels-Reid, Joy
Turtil, Steve
Watson, Anthony
Wolanski, Nicole
Zimmerman, Barbara

ODE Standards Liaison Representatives – FY 06 & FY 07

Abel, Dorothy
Adjodha, Michael
Allen, Peter
Allen, Samie
Anderson, Jodi
Baker, Karen
Beers, Everette
Berman, Michael
Berman, Sheryl
Betz, Bob
Bezabeh, Shewit
Blackwell, Angela
Bowley, Sue
Brooks, Mary
Brown, Daniel
Burdick, William
Byrd, Laura
Calogero, Don
Carey, Carole
Carstensen, Peter
Cavanaugh, Ken
Chen, Tzeng
Cheng, Jim
Choe, Melanie
Ciarkowski, Art
Colburn, Scott
Cornelius, Mary Jo
Cunningham, Terrell
Cygnarowicz, Teresa
Daws-Kopp, Kathryn
DeLuca, Robert
Demian, Hany
Doyle, Bob
Drum, Bruce
Eydelman, Malvina
Felton, Richard
Ferriter, Ann
Fox, Pat
Foy, Jonette
Gantt, Doyle
Gonzalez, Gema
Goode, Jennifer
Goode, John
Gouge, Susan
Graham, Ann
Guay, Justin
Hinckley, Steve
Ho, Charles
Holden, John
Holt, Vivianne
Husband, Michael
Jayan, Geetha
Jensen, Nick
Kaiser, Aric
Kammula, Raju
Kane, James
Kang, S. Andrew
Kaye, Ronald
Krause, David
Kuchinski, Michael
Lappalainen, Sharon
Lee, James
Lepri, Bernard
Letzing, Bill
Lin, Chiu
Lipman, Jason
Lochner, Donna
Maloney, William
Malshat, Vasant
Marshall, Felicidad
Mattamal, George
Mayhall, Elaine
McCarthy, Denis
McCool, Barbara
Melkerson, Mark
Michaud, Ginette
Mills, Kristin
Mulry, Kevin
Murphey, Sheila
Naveau, Irene
Nell, Diane
Nimmagadda, Venkat
Nutter, Cathy
Ogden, Neil
Panguluri, R. Kapil
Patel, Neel
Phillips, Robert
Pinto, Hina
Pollard, Collin
Rhodes, Stephen
Riley, Erin
Rios, Michelle
Ryan, Michael
Sauberman, Harry
Saviola, James
Schmidt, Jennifer
Schroeder, Marie
Shein, Mitchell
Shi, Dexiu
Shih, Ming-Chuen
Shiu, Lana
Smith, Myra
Soprey, Pandu
Tillman, Donna-Bea
Toy, Jeffrey
Turtil, Steve
Watson, Anthony
Warburton, Karen
Weitershausen, Joanna
Wentz, Catherine
Wood, Geretta
Yen, Dwight
Zaremba, Loren