R E S U M E
ROBERT F. MUNZNER, Ph.D.
OBJECTIVETo provide advice, consultation and
guidance concerning the scientific and regulatory requirements for marketing
medical devices in the United States, specializing in those devices used in
neurosurgery, neurology, and psychiatry.
EDUCATIONResearch Fellow, The Johns Hopkins University
School of Medicine, 1975-77
Ph.D., Biomedical Engineering, University of
B.S., Physics, Loyola College, 1963
SUMMARY OF QUALIFICATIONS
Twenty years of experience evaluating the documentation submitted to the U.S.
Food and Drug Administration to assure that medical devices are safe and
effective, and making recommendations concerning introduction of those devices
into interstate commerce. Made policy recommendations and directed the writing
of implementing regulations. Served for more than 15 years as Chief of the
Neurological Devices Branch in the Office of Device Evaluation and as Executive
Secretary of the Neurological Devices Panel, one year as Acting Chief of the
Anesthesiology and Respiratory Devices Branch, and six months as Acting Director
of the Division of Anesthesiology, Radiology, and Neurological Devices.
Appointed expert review scientist through FDA peer review committee.
PROFESSIONAL ACTIVITIESMember, IEEE New Standards
Committee, 1998 -- 2001; 2003 -- 2004
Member, IEEE Standards Board, 1999,
2000 and 2001
Chair, IEEE/EMBS Standards Committee, 1997 --
(See EMBS Standards
Chair, IEEE/EMBS National Capital Chapter,
(See EMBS Chapter Web
Site) Secretary, IEEE Northern Virginia Section, 2000
Member at Large,
IEEE/EMBS Administrative Committee, 2000 -- 2004
Vice Chair, IEEE/EMBS
Baltimore Chapter, 1997
Member, ASTM Standards
CSF Shunts, Cranial Tongs,
Aneurysm Clips, Stereotactic Equipment, and
Member, AAMI Standards
TENS Devices, ICP Monitoring
and Implanted Neurological
HONORS AND AWARDS
|IEEE Millennium Medal
|Senior Member, IEEE
|FDA CDRH Center Director's
| Award to Third-Party
| Recognition Team
|"Outstanding" Merit Pay Rating
|FDA/ODE 515(b) Task Force Recognition
|FDA Commissioner's Special Citation
|"Outstanding" Merit Pay Rating
|University Fellow (U. Virginia)
|Thornton Fellow (U. Virginia)
Strasburger & Price, LLP, Dallas, Texas, 2013.
Report & Deposition, Civil:
Williams & Connolly, LLP, Washington, D.C., U.S. District Court, Pennsylvania,
Synthes, Inc. v. Emerge Medical, Inc., Case No. 10-59265, 2013.
Wharton, Levin, Ehrmantraut & Klein, PA, Annapolis, Md., 2004.
Defenders Association of Philadelphia, Federal District Court,
U.S. vs. Fallon, 2003.
Declaration, Affidavit, Civil:
Howery, Simon, Arnold & White, LLP, Washington, D.C., 2002.
Consultation & Report, Civil:
Patton Boggs, LLP, Washington, D.C., 2002.
Michael Mallia, Attorney, Houston, TX, no trial, 2001.
Ollson, Frank & Weeda, PC, Washington, D.C, U.S District Court, San Francisco,
U.S. vs. Dieck, 2001.
U.S Department of Justice, Hearing re Dermatron Seizure, U.S. District Court,
Reno Nevada, 1990.
1999 -- present
Assist clients in the preparation of PMA's, IDE's and 510(k)'s.
1976 -- 1999: U.S Food and Drug Administration, Office of Device
Expert Review ScientistProvided scientific and regulatory
guidance to the Office of Device Evaluation and other FDA Offices regarding
complex and controversial issues associated with devices used in neurosurgery,
neurology, and psychiatry.
Chief, Neurological Devices BranchSupervised the work of
a group of seven scientists and engineers who reviewed premarket notifications
(510k's), premarket approval applications (PMA's) and investigational device
exemptions (IDEs). The Branch also drafted regulations concerning devices such
as implanted neurological electrical stimulators and electroconvulsive therapy
Acting Director, Division of Anesthesiology, Neurological, Radiology
DevicesProvided leadership to a group of 27 scientists, engineers,
and clinicians who evaluated new medical devices to assure safety and
effectiveness before marketing clearance.
Executive Secretary, Neurological Devices PanelRecruited
the best-qualified physicians and engineers to serve as FDA advisory panel
members, convened meetings of the Panel, and prepared the Panel agenda to obtain
expert advice on critical issues in the neurological field, including
applications to market new types of medical devices.
1975-1977, Johns Hopkins University School of Medicine
Research AssociateConducted independent physiological
research concerning the role of nervous system in the control of the heart and
blood circulation. Published the first report of a reflex action of the right
atrium affecting blood pressure.
1963-1969 Westinghouse Defense and Space Center
Engineer, Configuration ManagementExamined all proposed
changes to the AWG-10 airborne radar and its support equipment to assure
compatibility and logistics support functions were properly implemented
Negotiated detailed specifications for AWACS radar with prime contractor.
Logistics Support EngineerWrote and edited maintenance
and repair manuals for AWG-10 support equipment.
Munzner, R. "Obtaining an Investigational Device Exemption,"
Global Compliance Panel Webinar, www.globalcompliancepanel.com, September 2013.
Munzner, R. "U.S. Regulatory Requirements," in Wiley Encyclopedia of
Biomedical Engineering(M.Akay, editor), Wiley Publications, Hoboken, NJ, 2006.
Munzner, R. "Medical Devices: Regulations, Codes, and Standards," (chapter editor)
in Wiley Encyclopedia of Biomedical Engineering (M.Akay, editor), April 2006,
on line through WWW.Wiley.com.
Munzner, R., "The Role of Standards in FDA Marketing Clearance,"
IEEE Eng. Med. & Biol. Soc. Mag., 23/5 (Sept. 2004), p.89-90.
Munzner, R., "Informed Consent for a Device Investigation,"
IEEE Eng. Med. & Biol. Soc. Mag., 23/3 (May 2004), p.97-98.
Munzner, R., "U.S. Medical Device Classification,"
IEEE Eng. Med. & Biol. Soc. Mag., 23/1 (Jan. 2004), p.207-208.
Munzner, R., "Entering the U.S. Medical Device Market," Proc. 25th Ann. Int'l.
Conf. of the IEEE Eng. Med. & Biol. Soc., Sept. 17-21, 2003, Cancun, Mexico.
Munzner, R., "Marketing a Medical Device Without a 510(k): Exempt Devices,"
IEEE Eng. Med. & Biol. Soc. Mag., 22/5 (Sept. 2003), p.131.
Munzner, R., "What's in a 510(k)?," IEEE Eng. Med. & Biol. Soc. Mag., 22/3
(May 2003), pp. 157-158.
Munzner, R., "U.S. FDA rules for device investigations,"
IEEE Eng. Med. & Biol. Soc. Mag., 22/1 (Jan. 2003), pp. 95-96.
Kaufman, H.H. and Munzner, R.F. Chapter 2, Development and Standardization of
Medical Devices in "Neural Prosthesis," R.J. Maciunas Ed., American
Association of Neurological Surgeons, 2000. ISBN: 1-879284-73-1.
Kaufman, H.H. and Munzner. R.F., "Development and Standardization of Medical
Devices," in Neural Prostheses, R. Maciunas (ed.), American Assoc. of
Neurological Surgeons, 2000.
*Munzner, R.F. "Food and Drug Administration: Drugs and Devices," Vol. II,
Chapter 19, in The Physician's Perspective on Medical Law, H. Kaufman and
J. Lewin, (eds.), The American Association of Neurological Surgeons, 1997.
Kaufman, H.H., J. Lewin, R.F. Munzner, et al, "Ethical and Legal
Responsibilities of the Neurosurgeon," Neurosurgery, 28(1991), pp.918-923.
Munzner, R.F., "FDA Rules for the Medical Device Engineer," Proceedings of
the Tenth Annual Conference of the IEEE Engineering in Medicine and Biology
Society Special Symposium on Maturing Technologies and Emerging Horizons,
pp. 48-49, 1988.
Munzner, R.F., "FDA Regulation of Implanted Cerebellar Stimulators,"
Chapter 33 in: Cerebellar Stimulation for Spasticity and Seizures, R. Davis
and J.R. Bloedel (eds.), CRC Press Inc., Boca Raton, FL, 1984.
Munzner, R.F., D.G. Ward, and D.S. Gann, "Right Atrium Mediates a Vasomotor
Reflex ...," American J. Physiology, 241(1981), pp. R163-R166.
Munzner, R.F., S.R. Quint, and R.N. Johnson, "Response of Medullary Neurons to
Step-Changes in Carotid Sinus Pressure," Neuroscience Letters, 3(1976),
Baertschi, A.J., R.F. Munzner, D.G. Ward, R.N. Johnson, and D.S. Gann,
"Right and Left Atrial B-fiber Input to the Medulla of the Cat,"
Brain Research, 98(1975), pp.189-193.
Munzner, R.F., R.N. Johnson, and E.O. Attinger, "Response of Medullary Neurons
to Open-Loop Carotid Pressure Variations," (presentation to Federation of
American Societies for Experimental Biology), Federation Proceedings (abstr.),
Johnson, R.N., G.R. Hanna, and R.F. Munzner, "The Thalamocortical Motor System
and Stability: Observations of a Possible Regulatory Mechanism," Biological
Cybernetics, 18(1976), pp.91-104.
PRESENTATIONSChair for Mini-Symposium "MS-16, The Medical Device
Engineer Meets the FDA," International Conference of the IEEE Engineering in
Medicine and Biology Society, Chicago, October 30, 1997.
Breakfast Seminar Presentation, "Plates, Screws, Balloons and Glue,"
American Association of Neurological Surgeons, Orlando, April 24,1995.
Lectures: "Federal Regulation of Medical Devices" and " Phrenic Nerve
and Spinal Cord Stimulators," George Washington University Continuing
Engineering Education, Washington, D.C., February 21, 1995.
Session Chair, "Federal Regulation of Medical Devices," 16th Annual
Conference IEEE/EMBS, Baltimore, November 5, 1994. Presentation and panelist at workshop plenary session "The Role of
the Federal Government in Neural Prosthesis Research, Development and
Evaluation, " NIH, NINCDS Neural Prosthesis Workshop, NIH Lister Hill
Auditorium, Bethesda, Md., October 20, 1989. Co-Chair of plenary session: "Safety". International Motor Evoked
Potential Symposium, Sponsored by Chicago Neurosurgical Center, August 18, 1989.
Keynote Speaker for Special Symposium on "Maturing Technologies and
Emerging Horizons," 10th Annual IEEE/EMBS Conference, New Orleans, 1988. Session Chair, "The Impact of FDA Programs on the Medical Device
Industry," IEEE/EMBS Annual Conference, New Orleans, 1988. Panelist, "Functional Electrical Stimulation," 9th Annual IEEE/EMBS
Conference, Boston, 1988 Panelist, Business Plan Case Presentation, MIT Forum, November 13,
1984. Speaker, Workshop on Emerging Technologies in Neuroprostheses, Case
Western Reserve University, Cleveland, 1981.
CONTINUING EDUCATION1996, Workshop on Advances in MR
Safety and Compatibility
1989, Spring Semester, Forensic Medicine, FAES
Graduate School at NIH
1984, Laser Neurosurgery Workshop, UCLA School of
1984, NMR Imaging, NMR Concepts: The Traficante Series
Management of Intracranial Hypertension, American Academy of Neurology
Clinical Electroencephalography, American Academy of Neurology
Engineering in Hospitals, George Washington University
Carcinogenicity/Mutagenicity, Center for Professional Enhancement
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