FY 2005 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 2005.
Journals, Newsletter Articles and Book Chapters
Abel DB with Smith AC and Cavanaugh KJ. CAS Approval and Reimbursement. Endovascular Today 4(7):71-73, July 2005.
Abel DB and Smith AC. Exhibit Halls. Endovascular Today 4(3):77-78, March 2005.
Abel DB and Smith AC. Live Cases Involving Investigational Devices. Endovascular Today 4(1):71-72, January 2005.
Abel DB and Smith AC. The Preclinical Testing of Endovascular Grafts. Endovascular Today 3(10):63-64, November/December 2004.
Buckles D, Aguel A, Brockman R, Cheng J, Demian C, Ho C, Jensen D, and Mallis E. Advances in Ambulatory Monitoring: Regulatory Considerations. Journal of Electrocardiology 37:Suppl. 65-67, 2004.
Chakrabarti K, Thomas JA, Kaczmarek R and Romanyukha A. Contrast-Detail Phantom Scoring Methodology. Medical Physics 32(3), pp 807-814, March 2005.
Drum B, Kezirian G, and Eydelman M. Systematic Evaluation of Wavefront-Guided Outcomes. J Cataract Refract Surg 31(7):1306-1313, 2005.
Eydelman M. FDA’s Role in the Ophthalmic Device Evaluation Process. EyeWorld 9(11):12-13, November 2004.
Eydelman M. Collection of Clinical Data for an Unapproved Device. EyeWorld 10(2):8-9, February 2005.
Eydelman M. How to Obtain FDA Clearance to Market a New Ophthalmic Device. EyeWorld 10(6):30-31, May 2005.
Eydelman M. How to Obtain FDA Approval for a New High-Risk Ophthalmic Device. EyeWorld 10(8): August 2005.
Faris OP and Shein MJ. Government Viewpoint: U.S. Food & Drug Administration: Pacemakers, ICDs and MRI. Pacing Clin Electrophysiology 28(4):268-9, April 2005.
Faris O, Chen E, Berman M, Moynahan M, and Zuckerman B. A US Food and Drug Administration Perspective on Cardiac Resynchronization and Ventricular Assist Device Trials. Congestive Heart Failure 11(4):207-11, Jul-Aug 2005.
Felten RP, Ogden NR, Pena C, Provost MC, Schlosser MJ and Witten CM. The Food and Drug Administration Medical Device Review Process: Clearance of a Clot Retriever for Use in Ischemic Stroke. Stroke 36(2):404-406, February 2005.
Fuller J, Ashar BS, and Carey-Corrado J. Trocar-Associated Injuries and Fatalities: An Analysis of 1399 Reports to the FDA. J of Minimally Invasive Gynecology 12(4):302-307, July/August 2005.
Herrera H. Management with Continent Products. In: Incontinence, 3 rd International Consultation, Monte Carlo, Monaco, June 2005.
Jean RP, Gray DS, Spector AA and Chen CS. Characterization of the Nuclear Deformation Caused by Changes in Endothelial Cell Shape. Journal of Biomechanical Engineering 126(5):552-558, October 2004.
Jean RP, Chen CS and Spector AA. Finite-Element Analysis of the Adhesion-Cytoskeleton-Nucleus Mechanotransduction Pathway During Endothelial Cell Rounding: Axisymmetric Model. Journal of Biomechanical Engineering 127(4):594-600, August 2005.
Mann EA and Kane J. Interview regarding Sound Advice About Age-Related Hearing Loss. FDA Consumer 39(3):20-7, May-June 2005.
Mann EA, Burnett TA, Stoklosa JB, and Ludlow CL. Self-Triggered Functional Electrical Stimulation During Swallowing. J Neurophysiol 94(6):4011-8, December 2005.
Mann EA, Kearney PR, Poletto CJ, and Ludlow CL. Suppression of Thyroarytenoid Muscle Responses During Repeated Air Pressure Stimulation of the Laryngeal Mucosa in Awake Humans. Ann Otol Rhinol Laryngol 114(4):264-70, April 2005.
Mann EA, Puls I, Oh SJ, Sumner CJ, Wallace KE, Floeter MK, Kennedy WR, Wendelschafer-Crabb G, Vortmeyer A, Powers R, Finnegan K, Holzbauer EL, Fischbeck KH, and Ludlow CL. Distal Spinal and Bulbar Muscular Atrophy Caused by Dynactin Mutation. Ann Neurol 57(5):687-94, May 2005.
Mattamal GJ. Chapter 2: History and Background. In: Tissue Adhesives in Clinical Medicine by James V. Quinn, Second Edition, Hamilton, Ontario: BC Decker, Inc., pp. 15-26, 2005.
Mattamal GJ. Chapter 8: US Food and Drug Administration Perspective on Class I, II, and III Cyanoacrylate Medical Devices. In: Tissue Adhesives in Clinical Medicine by
James V. Quinn, Second Edition, Hamilton, Ontario: BC Decker, Inc., pp. 159-168, 2005.
Morris J. Interview regarding Controlling Urinary Incontinence. FDAConsumer 39(5):10-15, Sept.-Oct. 2005.
Muni NI, Ho C and Mallis E. Regulatory Issues for Computerized Electrocardiographic Devices. Journal of Electrocardiology 37:Suppl. 74-77, 2004.
Muni NI, Califf RM, Foy JR, Boam AB, Zuckerman BD, and Kuntz RE. Coronary Drug- Eluting Stent Development: Issues in Trial Design. American Heart Journal 149(3):415-33, March 2005.
Nelson CM, Jean RP, Tan JL, Liu WF, Sniadecki NJ, Spector AA, and Chen CS. Emergent Patterns of Growth Controlled by Multicellular Form and Mechanics. Proceedings of the National Academy of Sciences USA 102(33):11594-11599, August 2005.
Rhodes SP. Chapter 7: US Food and Drug Administration Perspective on the Regulation of Medical Device Tissue Adhesives. In: Tissue Adhesives in Clinical Medicine by James V. Quinn, Second Edition, Hamilton, Ontario: BC Decker, Inc., pp. 149-157, 2005.
Rinaldi JE, Chen EA, and Berman MR. Pediatric Circulatory Support: An FDA Perspective. American Society of Artificial Internal Organs Journal 51(5):533-535, September/October 2005.
Romanell L. 513(g) Request for Information - A Novel Process for Novel Devices. Regulatory Affairs Focus. Regulatory Affairs Professionals Society 10(8):14-16, August 2005.
Saviola J . The FDA’s Role in Medical Device Clinical Studies of Human Subjects. J Neural Eng 2(1):S1-4, March 2005.
Williams GA, Keegan P, Ogden NRP, Pazdur R, Temple R, and McClellan M. Chapter 57, Section 3: Regulatory Issues. In: CANCER, Principles and Practices of Oncology edited by Vincent DeVita, Samuel Hellman, and Steven Rosenberg, 7 th edition, Lippincott Williams & Wilkins, pp. 2767–2776, 2005.
Yahiro MA and Nakai K. Medical Device Clinical Trials in Japan. Medical Device and Diagnostic Industry 27(7):46-51, July 2005.
Abstracts and Presentations
Anderson JN. New Technologies in Spine Care. North American Spine Society Spring Break, Bal Harbour, FL, April 6-9, 2005.
Baskar HS, Lappalainen SK, and Hitchins VM. Cytotoxicity of residual cleaning agents used in reprocessing medical devices. FDA Science Forum, Washington DC, April 27-28 2005.
Boam AB. Current FDA Approach to Combination Products. Regulatory Affairs Professionals Society, Washington, DC, October 2004.
Boam AB. The FDA and Cardiovascular Device Regulation. Cardiovascular Research Foundation Interventional Cardiology Fellows Course, Boston, MA, April 15, 2005.
Boam AB. Clinical Trials for Combination Products. Drug Information Association Annual Meeting, Washington, DC, June 2005.
Boam AB. Development of Drug-Eluting Stents with New Drug Substances: FDA’s expectations. IIR Drug-Eluting Stent Conference, London, England (by telephone) July 2005.
Bowley S. Cardiovascular Medical Device Examples. Biomedical Engineering Society Annual Fall Meeting Workshop, Baltimore, MD, September 28, 2005.
Brockman, RG. Update on Trials of Atrial Flutter Ablation FDA Perspective. Heart Rhythm Society, New Orleans, LA, May 5, 2005.
Brockman RG. Surgical AF Ablation Clinical Trial Designs. Heart Rhythm Society, New Orleans, LA, May 5, 2005.
Brown SA. ICH Guidelines. Presentation at FDA Clinical Trials Course, Rockville, MD, May 2005.
Brown SA. HDEs and HUDs. Presentation at OHRP Human Subject Protection Seminar, Youngstown, OH, August 2005.
Buch B. FDA update: focused on labeling which requiring surgeons to be specifically trained to use a device before they can implant it. American College of Surgeons Committee on Emerging Technologies and Surgical Education, Palm Beach, FL, April 13, 2005.
Calogero D. ISO Clinical Investigation of IOLs – Required Modifications. ISO TC 172/SC7/ WG7 meeting, Ft. Lauderdale, FL, March 15, 2005.
Calogero D. Toric Power Requirements and the Optical and Mechanical Requirements for Accommodating IOLs. ANSI Z80.29 and ANSI Z80.30 meetings, Washington, DC, April 21, 2005.
Cavanaugh KJ. FDA Perspective on Medical Simulation-Based Training for Cardiovascular Devices. 2nd Annual Advanced Initiatives in Medical Simulation, Bethesda, MD, May 11, 2005.
Cavanaugh KJ. Role of CDRH in the Review of Combined Catheter/Cell and Gene Product Submissions. International Society of Endovascular Specialists International Congress XVIII, Scottsdale, AZ, February 13, 2005.
Cavanaugh KJ. FDA Approval and Post-Approval Studies. Society for Cardiovascular Angiography and Imaging Core Curriculum in Carotid Stenting, San Francisco, CA, September 9, 2005.
Chakrabarti K, Thomas J, Romanyukha A and Kaczmarek R. Image Viewing Conditions with Flat Panel Monitors. Annual Meeting of the Society of Computer Application in Radiology, Orlando, FL, June 2-5, 2005.
Chakrabarti K, Thomas J, Romanyukha A, and Kaczmarek R. Impact of Room Illuminance on Black Level Luminance and Contrast Detection for Off-axis Viewing on High Resolution Normal and High-Bright Panel Displays. Annual Meeting of American Association of Physicists in Medicine in Seattle, WA, July 23-28, 2005.
Chakrabarti K. Full Field Digital Mammography Imaging Chain-from Approval to Use. Breast Imaging Symposium, Breast Disease Diagnosis for the Future: A Forum to Share Practical Needs for Integration, Orlando, FL, June 4, 2005.
Chakrabarti K. Display Quality for Soft Copy Mammography Images. Mid-Atlantic States Radiation Control Programs, Centerville, DE, June 21, 2005.
Chen EA. FDA’s Perspectives on Rotary Blood Pumps. Heart Failure and Rotary Blood Pump Summit, Cleveland, OH, October 9, 2004.
Chen EA. What is a Name. FDA Round Table, Rockville, MD, January 2005.
Chen EA. Heart Failure Trials. Transcatheter Cardiovascular Therapeutics, Panel Member, Rockville, MD, October 19, 2005.
Chen EA. FDA Perspectives on Rotary Blood Pumps: Mid and Long Term. International Society for Rotary Blood Pumps, Tokyo, Japan, September 14-16, 2005.
Czerska E and Phillips R. FDA Regulation of IDE Devices. Society for Thermal Medicine 2005 Annual Meeting, Bethesda, MD, April 103, 2005.
Cygnarowicz T. What’s Happening in the Agencies: The Alphabet Soup of the Federal Government. American Academy of Audiology 17 th Annual Convention & Exposition, Washington, DC, March 31 - April 2, 2005.
Cygnarowicz T. Hearing Aids on the Internet - Is this an Option for You? American Academy of Audiology, 17 th Annual Convention & Exposition, Washington, DC, March 31-April 2, 2005.
Darouiche RA, Lin CS, Murphey SA, Morris JM, and Gantt AD. Closing the Gap Between Perspectives of Healthcare Providers, FDA and Industry. Fifth Annual Conference of the Center for Prostheses Infection/Multidisciplinary Alliance Against Device Related Infections, San Antonio, TX, August 6, 2005.
Demian H. Overview of CDRH Purpose and Function: Summary of the types of devices reviewed. Clemson University Department of Bioengineering Graduate Professional Workshop, Clemson, SC, October 22, 2004.
Drum B. Inclusion of Standard Outcomes Reports. 5 th International Congress of Wavefront Sensing and Optimized Refractive Corrections, Whislter, British Columbia, Canada, February 2004.
Drum B. Radial Efficiency Function in Refractive Surgery: Ablation losses caused by corneal curvature. Eleventh FDA Science Forum, Washington, DC, 2005.
Drum B. Federal Regulation of Vision Enhancement Devices for Normal and Abnormal Vision. Second Conference on Developments in Vision Enhancement Technology and their Evaluation, Morgantown, WV, 2005.
Elison CD, Hamad ML, Jefferson EH, Riemenschneider WK and Lyon RC. Process Understanding: Relating Scanning Electron Microscopy Studies of Powder Blends with Capsule Dissolution Performance. FDA Science Forum, Washington, DC, April 2005.
Eydelman M. Impact of Standards on Ophthalmic Device Evaluation in the U.S. Corporate Advisory Council for American Academy of Ophthalmology, Washington, DC, April 6, 2005.
Eydelman M. Ophthalmic Devices and Consensus Standards. International Society of Refractive Surgery (ISRS), Washington, DC, April 15, 2005.
Eydelman M. Impact of Standards on Ophthalmic Device Evaluation Process in U.S. ASCRS FDA Committee, Washington, DC, April 19, 2005.
Eydelman M. Accommodation Measures. ANSI Z80.29 Committee (Accommodating IOLs), Washington, DC, April 21, 2005.
Eydelman M, Drum B, Calogero D and Hilmantel G. FDA’s Critical Path Initiative for Evaluation of Devices for the Correction of Presbyopia. Eleventh FDA Science Forum, Washington, DC, April 2005.
Felten RP. Safety and Efficacy: Industry and the FDA: Why are safe but ineffective devices approved by the FDA. Conversations in Laser and Cosmetic Surgery Meeting, Denver, CO, August 14, 2005.
Felten RP. FDA Regulations and Review of Cosmetic Medical Devices. National Interstate Council of State Boards of Cosmetology. Washington, DC, August 26, 2005.
Foy JR. Combination Products: Challenges & Opportunities. Drug Information Association (DIA) Conference, Washington DC, June 2005.
Foy JR. Regulatory Considerations for Combination Products. Society of Toxicological Pathologists (STP) Conference, Washington DC, June 2005.
Foy JR. Hot Topics: Coronary Drug-eluting Stents as a Case Study. Cardiovascular Revascularization Therapy (CRT) Conference, FDA Think Tank, Washington, DC, March 28, 2005.
Foy JR. Regulatory Requirements for Drug-Device Combination Products: DES as a Case Study. Association for Official and Analytical Chemists Conference Irvine, CA, March 10, 2005.
Foy JR. DES & the Regulatory Process - Part B. Regulatory Affairs Professionals Society, San Francisco, CA, March 24, 2005.
Gonzalez G. Biomedical Engineering at the FDA. Biomedical Engineering Society, Baltimore, MD, September 30, 2005.
Harvey E. HDEs, HUDs and Orphan Products. AdvaMed Audioconference, September 2005.
Harvey E. Sponsor-Investigator Studies of Medical Devices. Pharmaceutical Education Associates Meeting, Philadelphia, PA, July 2005.
Harvey E. Regulations for Clinical Trials of Medical Devices. Biosensors Conference, NCI, Bethesda, MD, June 2005.
Harvey E. Medical Device Regulations. Office of Research Oversight, Veterans Administration bimonthly teleconference, May 2005.
Harvey E. Pre-IDE meetings and submissions. AdvaMed Annual Meeting, Washington, DC, May 2005.
Harvey E. HDEs, HUDs and Office of Orphan Products. AdvaMed Annual Meeting, Washington, DC, May 2005.
Harvey E. Medical Device Regulation: The Critical Path to New Medical Products: The Challenges in Protecting Human Subjects. DHHS Office of Human Research Protections, Houston, TX, April 2005.
Harvey E. AdvaMed MTLI Audio Conference: How to Plan for Pre-Market Meetings with CDRH, February 2005.
Harvey E. Unapproved Medical Devices: IDEs and GLPs. Medical Device and Manufacturers West 2005 Conference, Anaheim, CA, January 2005.
Harvey E. Medical Devices and Investigational New Drugs – The How To’s of Submission to the IRB and FDA. Contemporary Challenges in Biomedical Research. DHHS Office of Human Research Protections, Oklahoma City, OK, December 2004.
Harvey E. Humanitarian Device Exemption (HDE): An Overview. Second Dartmouth Device Development (3D2) Symposium, Woodstock, VT, October 2004.
Hillebrenner EJ. The Regulatory Pathway for Percutaneous Valve Therapies. Peripheral Angioplasty and All That Jazz, New Orleans, LA, April 28, 2005.
Ho C. Magnetic Catheter Navigation 101. FDA/CDRH Meet the Expert Series of Seminars, Rockville, MD, March 22, 2005.
Ho C and Mallis E (presenter). Utility and Limitations of the Warehouse Database: New ECG Device Development. International Society for Computerized Electrocardiology Conference , Hawaii , April 12-17, 2005.
Ho C, Jensen D, Lacy F, Muni N, Reilly S and Mallis E. Use of Standards in the Review of Medical Devices. International Society for Computerized Electrocardiology Conference, Hawaii, April 12-17, 2005.
Ho C, Jensen D, Lacy F, Muni N, Reilly S and Mallis E. Use of Standards in the Review of Medical Devices. FDA 2005 Science Forum, Washington, DC, April 27-28, 2005.
Holden J. Medical Device Regulations - From Research to Marketing: Orthopaedic Examples. Pre-conference workshop, the 2005 Annual Meeting of the Biomedical Engineering Society, Baltimore, MD, September 28, 2005.
Kaiser AD, McFarland RD, Dawisha SM and Leibenhaut S. Points to Consider in the Design of Nonclinical and Clinical Evaluations of Products Intended to Repair or Replace Articular Cartilage. FDA Science Forum. Washington, DC, April 27-28, 2005.
Kaiser AD. Medical Device Regulations-From Research to Marketing: Regulation of Bone Graft Substitutes. Pre-conference workshop, the 2005 Annual Meeting of the Biomedical Engineering Society, Baltimore, MD, September 29, 2005.
Kane J. Patient Perceptions Leading to Explanation (Cochlear Implants). Joint FDA/NISH Workshop, Rockville, MD, October 2004.
Karanian JW, Hilbert SL, Riemenschneider WK, Chiesa OA, Muray TL and Pritchard WF. Safety and Effectiveness of Drugs to Treat Vascular Disease Depend on Mode of Delivery: Per-Vascular Effects of Paclitaxel in Swine. FDA Science Forum, April 2005.
Lappalainen SK , Baskar HS, and Hitchins VM. Residual Total Protein Levels on Reprocessed Gastrointestinal (GI) Biopsy Forceps. FDA Science Forum, Washington DC, April 27-28, 2005.
Lerner H and Rhodes S. The FDA’s Perspective on Endpoints for Lipodystrophy. Regulatory Considerations for the Treatment of Lipodystrophy Round-table Discussion. George Washington University, Capitol Hill, Washington, D.C., October 25, 2004.
Lin C. Role of IRB in the Medical Device Approval Process in the U.S. National Council on Ethics in Human Research’s 2005 National Conference, Ottawa, Ontario, Canada, March 5-6, 2005.
Lin C. Regulation of Medical Devices in US. Medical Device Submission Workshop, Shanghai, China, July 10, 2005.
Lin C. Medical Device Submission Workshop. Jiangsu Province Food and Drug Administration, Shanghai , China , July 11-15, 2005.
Lin C and Murphey S. New FDA Guidelines for Antimicrobial-Coated Devices and Closing the Gap Between Perspectives of Healthcare Providers, FDA, and Industry. Conference on Clinical Advances, Technologic Enhancements, and New Regulations: Optimizing the Multidisciplinary Care of Patients with Device-Related Infections sponsored by the Center for Prostheses Infection (CPI) and the Multidisciplinary Alliance Against Device-Related Infections, San Antonio, TX, August 5, 2005.
Lin CS, Murphey SA, Morris JM, and Gantt AD. New FDA Guidelines for Antimicrobial-Coated Devices. Fifth Annual Conference of the Center for Prostheses Infection/Multidisciplinary Alliance Against Device Related Infections, San Antonio, TX, August 5, 2005.
Lochner DR . Regulatory Considerations for Tissue Based Cardiovascular 2005 ETG Executive Forum, Atlanta, GA, June 1, 2005.
Mann EA. Head and Neck Embryology. 40 th Annual AFIP Basic Science Course in Otolaryngology, Washington, DC, February 2005 .
Mattamal GJ. FDA’s Perspective on the Regulations of Cyanoacrylate Tissue Adhesive Medical Device Technology. American Chemical Society National Meeting, San Diego, CA, March 13-17, 2005.
Melkerson M. PMA Pre-submission meetings. PMA Submission and Supplements Workshop sponsored by AdvaMed, Arlington, VA, April 7, 2005.
Melkerson M. CDRH liaison to the F04 Main Committee. Medical Devices and Implants of the American Society for Testing and Materials semi-annual meeting. Reno, NV, May 18-20, 2005.
Melkerson M. DGRND update. AdvaMed Annual Device Submissions Workshop, Arlington, VA, May 24-25, 2005
Melkerson M. Medical Device Regulations: from Research to Market. Medical Device Regulations, chairperson. Pre-conference workshop, the 2005 Annual Meeting of the Biomedical Engineering Society, Baltimore, MD, September 29, 2005.
Melkerson M and Stevens T. Orthopaedic and Restorative Devices Updates. Orthopedic Surgical Manufacturers Association. Annapolis, MD, October 8, 2004.
Melkerson M and Stevens T. Orthopaedic and Restorative Devices Updates. Orthopedic Surgical Manufacturers Association, Baltimore, MD, April 15, 2005
Mezu O, Mezu K, and Nwaba N. Prevention of Infection in Sickle cell Disease Patients. The Sickle Cell Disease Association’s 33 rd Annual Convention, Baltimore, MD, September 7-10, 2005.
Michaud G. Supplemental Validation Submissions for Reprocessed Single Use Devices. MDUFMA Stakeholder Conference, Gaithersburg, MD, November 18, 2004.
Michaud G. Reprocessing of Single Use Devices. AdvaMed, Arlington, VA, May 2005.
Michaud G. Globally Harmonized Premarket Oversight and Principles of Conformity Assessment for Medical Devices. Global Harmonization Task Force Joint Study Group, Gaithersburg, MD, September 16, 2005.
Morris J. Review Criteria for Medical Devices that Use Antimicrobial Agents. 2005 Center for Prostheses Infection (CPI)/Multidisciplined Alliance for Device Related Infections (MADRI) Conference in San Antonio, TX, August 5-7, 2005.
Moynahan M. What is Off-Label Use? Heart Rhythm Society Annual Meeting, New Orleans, LA, May 8-11, 2005.
Nguyen T. PMA Guidance Updates. 15th Annual AdvaMed Device Submission Workshop, Arlington, VA, May 24-25, 2005.
Nguyen T. Contents of a Successful Premarket Submission. AdvaMed PMA 101 Submission Workshop, Crystal City, VA, March 2005.
Nutter C. FDA’s Recognition and Use of Consensus Standards for Medical Packaging. IoPP Symposium, Health Pack Conference, San Antonio, TX, March 2005.
Pena C. Clinical Trial Design Issues for Neurologic Devices and Power Analyses. National Institute of Neurological Disorders and Stroke, NIH, Rockville, MD, September 2005.
Pena C. Medical Device Regulations - From Research to Marketing: Neurologic Products. Pre-conference workshop, the 2005 Annual Meeting of the Biomedical Engineering Society. Baltimore, MD, September 28, 2005.
Pereira A. Adult Tonsillectomy – Update 2005. Baltimore-Washington Chapter of the Society of Otolaryngology/Head and Nurses Meeting, August 2005.
Phillips P. FDA Experience with Standards in Submissions. AdvaMed Standards Conference (“Use of Standards and Submissions”), Alexandria, VA, February 2-3, 2005.
Pollard C. Regulatory Considerations for Medical Devices. Harvard-MIT Biomedical Enterprise Program, Cambridge, MA, April 2005.
Rechen E. Third Party Review: Is This the Right Path for Your 510(k)? RAPS 2004 Annual Conference & Exhibition, Washington, DC, October 2004.
Rechen E. Using the Third Party Review Program. AdvaMed’s 15 th Annual Device Submissions Workshop, Arlington, VA, May 24, 2005.
Rechen E. Third Party Review of 510(k)s—FDA Viewpoint. MD&M East Conference. New York, NY, June 2005.
Rinaldi J, Chen E, and Berman M. Pediatric Circulatory Support: An FDA Perspective. Pediatric Mechanical Circulatory Support Conference, Hershey, PA, May 19-22, 2005.
Rhodes SP. CDRH Regulation of Tissue Engineered Medical Products. T he Tissue Engineering Symposium at the 30 th Annual Meeting of the Society of Biomaterials. Memphis, TN, April 2005.
Rhodes, SP. CDRH Perspective on the Regulation of Cyanoacrylate Tissue Adhesives. 30th Annual Meeting of the Society of Biomaterials, Memphis, TN, April 2005.
Romanell L. 510(k) Submissions – 101. Presentation at AdvaMed Submissions Workshop. Crystal City, VA, April 2005.
Rosecrans H. Regulatory Affairs and 510(k). University of Washington, Graduate School, Seattle, WA, November 2004.
Rosecrans H. 510(k) Program. Organization of Regulatory and Clinical Associates, Seattle, WA, November 2004.
Rosecrans H. How to Plan for Premarket Meetings with CDRH. AdvaMed, Rockville, MD, February 2005.
Rosecrans H. 510(k) Update. Medical Device Industry Initiatives Grassroots Task Force Meeting, Seattle, WA, March 2005.
Rosecrans H. 510(k) Update. Organization of Regulatory and Clinical Associates (ORCA) Meeting, Kirkland, WA, March 2005.
Rosecrans H. Device Premarket Update. International Society for Pharmaceutical Engineers/Educational Forum, Durham, NC, March 2005.
Rosecrans H. Practical Considerations in Preparing 510(k)s. Association of Medical Device Manufacturers - AMDM/FDA OIVD Workshop, Rockville, MD, April 2005.
Rosecrans H. What a Great 510(k) Should Look Like. AdvaMed’s 15 th Annual Device Submissions Workshop, Arlington, VA, May 2005.
Rosecrans H. Medical Device Regulatory Update. North Carolina Medical Device Organization (NCMD, Triangle Park, NC, May 2005.
Rosecrans H. New Guidance in 510(k). Grassroots Task Force, Washington, DC, September 2005.
Rosecrans H. 510(k) Update and Training. MDMA, Boston, MA, September 2005.
Rosenthal R and Eydelman M. A Guide to Ophthalmic Device and Drug Evaluation. American Academy of Ophthalmology, New Orleans, LA, October 24, 2004.
Sapirstein W. Overcoming Road Blocks. An FDA Perspective. Transcatheter
Valve Symposium, Chicago, IL, March 2005.
Shad AD, Olsen LE, Pritchard WF, Hilbert SL, Riemenschneider WK and Karanian JW. Pharmacokinetics of Local Drug Delivery Depends on Mode of Delivery and Hemodynamices in an In Vitro Vascular Flow Model. FDA Science Forum, April 2005.
Shulman M. Basic 510(k) Overview. Advanced 510(k) Issues. Medical Design and Manufacturing (MD&M) West Conference, Anaheim, CA, January 2005.
Shulman M. Bringing Foreign Produced Devices to U.S. Markets. MEDTEC Germany 2005, Stuttgart, Germany, February 2005.
Shulman M. 510(k) Submission 101 Workshop, AdvaMed, Crystal City, VA, April 2005.
Shulman M. Basic 510(k) Overview. Advanced 510(k) Issues. Medical Design and Manufacturing (MD&M) East, New York, NY, June 2005.
Smith A. FDA Review of Venous Devices: A Case Study of IVC Filters. American Venous Forum Annual Meeting, San Diego, CA, February 9, 2005.
Stevens T. Combination Products with Biological Material: US FDA Perspective.
Regulatory Affairs Professionals Society West Coast Conference and Exhibition, San Francisco, CA, March 23, 2005.
Stuart J. New Format Guidance for 510(k). NEMA. Arlington, VA, September 2005.
Tillman DB. Career Experiences. Johns Hopkins University, Biomedical Engineering Department, 2004-2005 BME Career Paths Seminar Series, Baltimore, MD, October 14, 2004.
Tillman DB. Biomaterials in the 21st Century: Overcoming Obstacles on the Critical Path to Medical Device Development. Surfaces in Biomaterials Foundation Symposium, BioInterface, Baltimore, MD, October 27-29, 2004.
Tillman DB. Expanding Turbo 510(k) into ODE. AdvaMed’s Annual Device Submissions Workshop, Arlington, VA, May 24, 2005.
Tillman DB. Human Factors: Keeping Good Devices from Going Bad. AAMI Conference on Human Factors, Ergonomics, and Patient Safety for Medical Devices, Washington, DC, June 28, 2005.
Tillman DB. Working with the FDA. 12 th annual Healthcare CEO Summit, La Jolla, CA, July 18, 2005.
Tillman DB. Fostering Innovation; the role of the Federal Government in our Future. BME – Innovation, Design and Entrepreneurship Alliance Meeting, Baltimore, MD, September 28, 2005.
Turtil S. 510(k) Submission Sterilization Issues including Traditional and Non-traditional, Sterilization Methodologies Reprocessing SUDS. Third party 510(k) Reviewer Training program, Gaithersburg, MD, October 26 & 27, 2004.
Turtil S. Reprocessing Single Use Devices. MDUFMA Stakeholder Conference, Gaithersburg, MD, November 18, 2004.
Witten C. Tissue and Tissue Engineering. From Concept to Consumer Workshop, Gaithersburg, MD, October 7, 2004.
Witten C. Post Approval Studies of Medical Devices. Regulatory Affairs Professional Society, Washington, DC, October 12, 2004.
Witten C. The approval of the Concentric retriever and the approval of devices for acute stroke in general. International Stroke Conference, New Orleans, LA, February 2-4, 2005.
Yustein R. Regulatory Issues of Endoscopic Innovation. Innovation in Endoscopy “Future Vision 2005” summit meeting sponsored by the American Society for Gastrointestinal Endoscopy, Rancho Mirage, CA, March 10-11, 2005.
Staff College Presenters and Faculty
|Boam, Ashley |
|Horbowyj, Roxolana |
Jensen, D. Nick
|Nguyen, Thinh |
ODE Standards Liaison Representatives
|Abel, Dorothy |
Cornelius, Mary Jo
|Gonzalez, Gema |
|Nell, Diane |