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To 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.


Research Fellow, The Johns Hopkins University School of Medicine, 1975-77
Ph.D., Biomedical Engineering, University of Virginia, 1976
B.S., Physics, Loyola College, 1963


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.


Member, IEEE New Standards Committee, 1998 -- 2001; 2003 -- 2004
Member, IEEE Standards Board, 1999, 2000 and 2001
Chair, IEEE/EMBS Standards Committee, 1997 -- 2003
      (See EMBS Standards Committee)
Chair, IEEE/EMBS National Capital Chapter, 1998-1999
(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 Subcommittees:
     CSF Shunts, Cranial Tongs,
     Aneurysm Clips, Stereotactic Equipment, and Neurosurgical Sponges
Member, AAMI Standards Subcommittees:
     TENS Devices, ICP Monitoring Devices,
     and Implanted Neurological Stimulators


IEEE Millennium Medal 2000
Senior Member, IEEE 1997
FDA CDRH Center Director's 1997
     Award to Third-Party
     Recognition Team
"Outstanding" Merit Pay Rating 1995
FDA/ODE 515(b) Task Force Recognition 1993
FDA Commissioner's Special Citation 1989
"Outstanding" Merit Pay Rating 1988
University Fellow (U. Virginia) 1972-1974
Thornton Fellow (U. Virginia) 1971



Report, Civil:
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.

Consultation, Civil:
Wharton, Levin, Ehrmantraut & Klein, PA, Annapolis, Md., 2004.

Testimony, Criminal:
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.

Deposition, Civil:
Michael Mallia, Attorney, Houston, TX, no trial, 2001.

Affidavit, Criminal:
Ollson, Frank & Weeda, PC, Washington, D.C, U.S District Court, San Francisco, U.S. vs. Dieck, 2001.

Testimony, Criminal:
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 Evaluation

Expert Review Scientist

Provided 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 Branch

Supervised 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 devices.

Acting Director, Division of Anesthesiology, Neurological, Radiology Devices

Provided 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 Panel

Recruited 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 Associate

Conducted 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 Management

Examined 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 Engineer

Wrote 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.),
 34(1975), p.407.
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.


Chair 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, 
Speaker, Workshop on Emerging Technologies in Neuroprostheses, Case 
Western Reserve University, Cleveland, 1981.


1996, 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 Medicine
1984, NMR Imaging, NMR Concepts: The Traficante Series
1982, Management of Intracranial Hypertension, American Academy of Neurology
1982, Clinical Electroencephalography, American Academy of Neurology
1978, Medical Engineering in Hospitals, George Washington University
1978, Carcinogenicity/Mutagenicity, Center for Professional Enhancement

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March 5, 2015
Robert F. Munzner, Ph.D.
790 Foggy Bottom Road
Schuyler, VA 22969