SUZANNE PARISIAN, M.D

EMPLOYMENT HISTORY:

8/95- PRESIDENT
MD ASSIST, Inc.
7117 N. 3rd Street
Phoenix, Arizona 85020

12/1993-7/95 CHIEF MEDICAL OFFICER
Division of Reproductive, Abdominal, Ear, Nose and
Throat, and Radiology (DRAERD)
OFFICE OF DEVICE EVALUATION (ODE)
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)
FOOD AND DRUG ADMINISTRATION (FDA)

8/1991-7/95 Lt. Commander
United States Public Health Service

8/1991-3/1993 Medical Officer
Office of Health Affairs (OHA)
Center for Devices and Radiological Health(CDRH)
FOOD AND DRUG ADMINISTRATION (FDA)

4/1993-11/93 Medical Officer
Division of Reproductive, Abdominal, Ear, Nose &
Throat, and Radiology (DRAERD)
Office of Device Evaluation (ODE)
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration (FDA)

8/1991-7/95 Clinical Staff Appointment
Office of the Medical Examiners for Armed Forces
Armed Forces Institute of Pathology (AFIP)
Washington, D.C.

4/1985-6/1987 General Practice
Avtex Fibers, INC
Front Royal, Virginia

4/1980-7/1981 Emergency Medicine
President
Mountain Emergency Medical
Caldwell Memorial Hospital
Lenoir, North Carolina

10/1979-3/1980 General Practice
Caldwell County Health Department
Lenoir, North Carolina

CDRH / FDA /HHS & USPHS HONORS:DEPARTMENT OF HEALTH AND HUMAN SERVICES
Employee of the Month: August l993

FOOD AND DRUG ADMINISTRATION
Employee of the Month: August 1993

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Employee of the Month: August 1993

Public Health Service's Achievement Medal- 1992

Public Health Service's Unit Commendation Medals
Acupuncture Workshop- 1995
Total Parenteral Nutrition Complications Group- 1995
Night Vision Equipment Radiation Leak Group- 1995
Anesthesia Heated Wire Circuit-1994
Small-Bore Anesthesia Group-1992
Corporate-Wide Injunctions Groups-1993, 1994, 1995

Public Health Service's Commendation Medal
Neonatal Ventilators-1992
Hemodialyzer Reuse Labeling-1995

Public Health Service's Unit Citations- 1992, l992
Latex Allergy-1993

Nominee for FDA Honor Award
FDA's Policy for Hyperthermia Clinical Trials-1995

Certificate of Appreciation CDRH's Staff College
Clinical Trials Course, Spring, 1995

Other Honors
University of Central Florida, Cum Laude, l974
University of Central Florida, Summa Cum Laude, l975

REGULATORY ACTIVITIES:

OFFICE OF DEVICE EVALUATION (ODE) PRIMARY RESPONSIBILITY:
Primary responsibilities included:

1) Review of FDA Premarket applications-
510Ks,Investigational Device Exemption(IDEs), Premarket
Approval Applications (PMAs)) including design, labeling,
health issues and quality systems requirements for
manufacturing issues; INDs.
2) Review and evaluation of clinical trials, etc;
3) Design of Post Marketing Clinical Studies;
4) Health Risk Assessments and management for Office of
Compliance and the FDA District Field Offices;
5) Liaison for manufacturers, clinical investigators,
government agencies, medical community, press, Congress,
patient advocate groups, public, and manufacturer's
organizations;
6) Training of ODE clinical reviewers;
7) Quality Assurance design;
8) Identification and resolution of safety and efficacy issues;
9) Presentation of clinical device issues to FDA Advisory Panels;
10) Presentation of Device-related issues to
Health Care Financing Administration's Technology
Assessment Committee (HCFA, TAC);
11) Investigator and Manufacturer Guidances from CDRH
for Clinical Protocols;
12) Clinical support for FDA regulatory actions and hearings.

CLINICAL DEVICE RESPONSIBILITY AREAS in ODE:
ENT - Cochlear implants, brainstem implants;
Radiology - Magnetic Resonance Imaging, Ultrasonography, Mammography,
Radiation Hyperthermia Therapy, Neurosurgical Imaging Systems,
Interventional Radiology, Thermography, Radiotherapy;
Urology- cryosurgery, lasers, stents, penile prostheses,
urethral implants, lithotripsy;
Extracorporeal circulation - Hemodialysis, LDL-Apheresis, Plasmapheresis,
Immunadsorption, Cell Harvest; Organ Preservation;
Pulmonary- bronchoscopy, stents;
Gynecology- infertility, PAP smear technology;
Obstetrics- chorionic villus sampling, amniocentesis, fetal monitoring;
Gastroenterology- biliary stents, neuromuscular stimulators;
Endoscopy & Laparoscopy; Lasers;
Alternative Medicine for FDA;
Immunology;
In vitro diagnostics; Toxicology; Cytology;
Biological Artificial Organ Assist Devices (Center for Biologics Evaluation and Review (CBER);
Implanted Neuroelectrical Stimulators;
Genetics; Perinatology;
Transfusion Medicine; Electromagnetic Fields and Interference;
Tissue and Organ Transplantation (CBER);
Forensics
Combination Products-Drug/Device, Biologics/Device
Contrast Agents

100 Health Risk Assessments while in ODE

OFFICE OF HEALTH AFFAIRS PRIMARY RESPONSIBILITY:
1) Primary support for Office of Compliance-
Health Risk Assessments & Health Hazard
Evaluations; review of Labeling, Mandatory Device
Reports (MDRs), Adverse Experience Reports (AERs)
2) Interaction with manufacturers, investigators, health care
providers, professional organizations;
3) Interaction with FDA District Offices, other government
agencies, the Office of Device Evaluation;
4) Identification of public health and safety issues.

Primary Clinical Responsibility Areas for OHA:
Cardiovascular; Anesthesia; Pulmonary;
Orthopedics; Unconventional Therapies;
Rehabilitative Medicine; Pathology; Home Health;
Emergency Medicine; Hemodialysis; Toxicology; Radiology

162 Health Risk Assessments while in OHA

FORENSIC MEDICINE CLINICAL ACTIVITIES:

Evaluation of Patient Cause of Death & Injury with FDA regulated products

Review and Final Sign-Out Cause of Death Military, Dependent,
FBI and CIA
Armed Forces Institute of Pathology
Office of Medical Examiner
Washington, D.C.

Center for Devices and Radiological Health (CDRH) Assigned Support:

Anesthesia Post Market Surveillance Chairman (l992- May, l993)
FDA and CDRH's Liaison for Alternative Medicine
CDRH Staff College Instructor, Clinical Trials
Temple Tier II Report-ODEs Internal Quality Assurance (QA) Review

CDRHs Representative
National Kidney and Urological Diseases Advisory Board
National Institutes of Health
Health Care Financing Administration's Technology Assessment Committee
Ad Hoc Working Group CDRH Transfusion Medicine

CDRHs Support for FDA's Office of Legislative Affairs (OLA) and Press Office for:
Extracorporeal Hyperthermia and treatment of patients with AIDS;
Alternative Medicine;
Hemodialysis

LECTURES While at FDA:

Armed Forces Institute of Pathology
Essentials of Medical Devices and Death Investigations
Washington, D.C.
October, 1993

Third World Conference of Acupuncture
FDA's Viewpoint of Acupuncture
Kyoto, Japan
November, l993

Alternative Medicine Conference
FDA's Viewpoint of Acupuncture
Smithsonian Museum of Medicine
National Museum of Medicine
Washington, D.C.
December, 1993

Reuse of Hemodialyzers
Office of Device Evaluation
Presentation and Review of CDRHs Draft Guidance Document
Rockville, Maryland
December, 1993

Panel Chairman
Office of Alternative Medicine/National Institutes of Health (OAM/NIH)
Workshop for Acupuncture Needle Reclassification
Provided FDA's Viewpoint
Rockville, Maryland
April, 1994

National Acupuncture and Oriental Medicine Alliance
Annual Conference
FDA's Viewpoint - Acupuncture
Crystal City, Virginia
May, 1994

OAM/NIH and FDA's Workshop Planning Group
for Herbs Conference,
FDAs and CDRHs policy
For Alternative Medicine Providers
Rockville, Maryland
May, 1994

American Association for Medical Instrumentation (AAMI)
FDAs perspective Hemodialysis Reuse Labeling Guidance
Washington, D.C.
June, 1994

AAMI Conference
FDA's Recommendation for Hemodialyzer Reprocessing Labeling
Hemodialysis Reuse Section
Washington, D.C.
June, 1994, November 15, 1994
& May 9, 1995 (Joint AAMI/HIMA Workshop)

FDA's Genitourinary Advisory Panel
Presentation Hemodialysis Reuse Labeling Guidance
Rockville, Maryland
July, 1994 &
January 1995

FDA Urology Devices Advisory Panel Meeting
Presentation of LDL-Apheresis Premarket Applications
Kaneka's Liposorber LA-15 System
B.Braun of America's H.E.L.P. System
Rockville, Maryland
April, 1995

FDA's ENT Advisory Panel Meeting
Presentation of Cochlear's Nucleus 22 Cochlear Implant
PMA application- expansion of patient population
Rockville, Maryland
April, 1995

Second Symposium of Society for Acupuncture Research (SAR)
Georgetown University Conference Center
Government's perspectives on clinical trials for acupuncture
Washington, D.C.
September 17, 1994

FDAS CHAIRMAN
Reuse of Hemodialyzer,
Rockville, Maryland
December 10, 1993
May 1995

LECTURES, INTERVIEWS & ACTIVITIES After FDA:

FDA and Acupuncture
ABC News Interview
Los Angeles, CA
Summer 1995

Dealing with Adverse Events
1996 National Sales Meeting
Johnson & Johnson Medical Inc.
Dallas, Texas
April 1, l996

Dialyzers Labeled for Reuse
The Manufacturer's Responsibilities
Fifth Annual Spring Clinical Nephrology Meeting
National Kidney Foundation
Anaheim, CA
April 27, l996

Challenges with Infusion Therapy Complications
Intravenous Nursing Society
Charlotte, North Carolina
May 7, l996

510(k) Tutorial
Food Drug and Law Institute
40th Annual Educational Conference
Washington, D.C.
December 9, l996

FDA Expert Panel Member
Medical Devices: Device Labeling Requirements
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
September 5, l997

Science and Art of Designing Successful Medical Device
Clinical Trials for the FDA- A Workshop
Institute for International Research, Pharmaceutical Division
Santa Monica, CA
September 22-24, l997

What You May Need to Know about Medical Devices
And FDA But Never Would Have Thought to Ask.
22nd Annual Great Lakes Biomedical Conference
Engineering in Medicine and Biology Society
Milwaukee School of Engineering
Milwaukee, Wisconsin
April 3, l998

ABC News Interview with Ron Regan
Medical Device Reporting for Surgical Trocar Injuries
WEWS ABC - Channel 5 News
Cleveland, Ohio
May 17, 2001

Interview in:The Trouble with Trocars
By Linda Carroll & Alfred Lubrano
Smart Money
The Wall Street Journal Magazine of Personal Business, Hearst Communications
New York, NY
November 2001

FDA Inside and Out- Public Health Issues in Cervical Cancer Screening
Global Vista Medical Foundation
Sponsored by President Medical technologies Co., LTD
Taipei, Taiwan, R.O.C.
March 3, 2002

Inside the FDA
Presentation to Kent County Medical Society
Grand Rapids, MI
May 14, 2002

Clinical Trials
What physicians need to know
Medical Grand Rounds
St. Marys Hospital
Grand Rapids, MI
May 15, 2002

Interview in:The Risky World of Medical Implants
A Three Part Series
Robert Cohen and J. Scott Orr
Star Ledger
Morris Edition, New Jersey
August 11-13, 2002

NBCs Dateline Interview with Lea Thompson
Special Investigations-Do No Harm-Sulzers Hip Recall
NBC News Washington
Washington, D.C.
*2004 Emmy Outstanding Investigative Reporting Business News Story
*2004 Edward R. Morrow Television Investigative Reporting
July 25, 2003

Interview with Author Barbara Seaman
History of FDAs Clearance of Bone Densitometers, page 78
The Greatest Experiment Ever Performed on Women
Published by Hyperion, New York, New York
Fall 2003

InterviewIs This Any Way to Have a Baby? The Terrifying Truth About Fertility Drugs.
Barbara Seaman and Joanna Perlman
OPRAH Magazine, beginning page 188
Published by Hearst Communications Inc., New York, New York
February 2004

InterviewWarning! The Medical Miracles That May Be Hazardous to Your Health.
Alexis Jetter
Good Housekeeping Magazine, beginning page 138
Published by Hearst Communications Inc., New York, New York
March 2004

InterviewInvestigation of FDAs Oversight of Mammography Facilities.
Producer Mary Schwager
Investigative News
WHDHTV-NBC
Boston, MA
October 19, 2004

Bayer Stroke Trial Continues
Tim Gurrister
Top of Utah
Salt Lake City, UT
January 22, 2005

Drugs, Informed Consent and Monitoring to Ensure Safety of Women for Stem Cell Donation
Open Letter of Suzanne Parisian, MD
Presented to California Legislature and Massachusetts Legislature
Released February 2005

Open Letter Suzanne Parisian, MD
Chapter 25-Infertility and Assisted Reproduction
Emerging Biotechnologies: Cloning
Our Bodies Ourselves
Boston Womens Health Book Collective, Inc.
Boston, MA
March 2005

Interview Stem Cell Research & Egg Donation
Martha Bebinger
WBUR NPR Radio
Boston, MA
April 2, 2005

Interview in Exposed Nerve
Craig Malisow
Houston Press
Houston, TX
April 7, 2005

Public Statement-Regarding Two Pending PMAs
On Behalf of ProChoice Alliance for Responsible Research (PROCARR)
General & Plastic Surgery Devices Panel
Center for Devices and Radiological Health
Food and Drug Administration
Gaithersburg, MD
April 11, 2005

FDAs History of Silicone-Gel Filled Breast Implants
Briefing of US House of Representatives and US Senate Staff
Washington, DC
April 25, 2005

Conference - Two Pending PMAs
Presentation to FDA Commissioner Dr. L. Crawford
Food and Drug Administration
Washington, DC
April 26, 2005

Public Statement Two Pending License Applications
Health Canada Therapeutic Products Expert Review Panel
Ottawa, Canada
September 29, 2005

FDA & CLIA
Trends in Medical Diagnostic Commercialization

Arizona Biotechnology Association
Phoenix, AZ
February 7, 2006

ABC Interview Nightline
Fertility Myth
Producer Mary C. Foster
May 30, 2006

VOLUNTARY STANDARDS COMMITTEE INVOLVEMENT

Has been an active member of the following committees for
AMERICAN SOCIETY for TESTING MATERIALS (ASTM)
Medical and Surgical Material and Devices
Occupational Health and Safety
Search and Rescue
Anesthetic and Respiratory Equipment
Forensics
Biotechnology

AMERICAN ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION (AAMI)
Renal Disease and Detoxification Committee

PUBLICATIONS:

Homoeotic Effect of the Tumorous-Head Mutant and Differential Effect
of an Enhancer Gene in the Tumorous-Head Strain of Drosophila Melanogaster
,
Canadian J Genet. and Cytology, 1975; 17:423-432.

Latex Allergy and Anesthesiology.
Anesthesia Patient Safety Foundation Newsletter
Spring, l992.

The Potential for Adverse Reactions Due to the Presence of Additives and
Preservatives in Intravenous Solutions and Medications
;
Journal Vascular Access Devices, Winter 1996, Vol 1 (1): 5-14.
*Sponsored by Johnson & Johnson Medical, Inc.

Letter to the Editor, Midline Catherization in Hospitalized Patients.
Annals of Internal Medicine, October 15, l996; Vol 125, No 8: p 697.
*Sponsored by Johnson & Johnson Medical, Inc.

FDA INSIDE and OUT,
S. Parisian, M.D.
Publication May, 2001
Fast Horse Press, Inc.

DATE AND PLACE OF BIRTH:
September 20,1952,
Rapid City, Pennington County, South Dakota

MARITAL STATUS:
Married- August 26, 1977

FAMILY:
Son 02/09/1985
Daughter 09/12/1986

MEDICAL LICENSURE:
State of Virginia
State of Arizona

EDUCATION:
6/1970-6/1974 Bachelors of Science
University of Central Florida
Orlando, Florida

7/1994-6/1975 Masters of Science
University of Central Florida
Orlando, Florida

7/1975-6/17/1978 Medical Doctorate
University of South Florida
Tampa, Florida

TRAINING:

7/1/1978-6/30/1979 Flexible Internship
Greenville Hospital System
Greenville, South Carolina

9/14/1981-6/30/1982 Pathology Resident
University of California, San Diego
San Diego, California

7/1/1982-2/29/1984 Pathology Resident
University of Southern California
Los Angeles County Medical Center
Los Angeles, California

1/4/1988-1/30/1990 Pathology Resident

Grand Rapids Area Medical Education Center
Grand Rapids, Michigan

BOARD CERTIFICATION:

Board Certified in Anatomic and Clinical Pathology, 1989, American Board of Pathology
College of American Pathologists, Fellow (FCAP)
American Society of Clinical Pathologists, Fellow (FASCP)

SOCIETIES:

American Medical Association
Arizona Medical Association
Arizona BioIndustry Association
Maricopa County Medical Society
American Advancement for Medical Instrumentation
American Society for Testing Materials
Regulatory Professionals Society
Food and Drug Law Institute
College of American Pathologists
Food and Drug Alumni Association

OFFICE ADDRESS:

MD ASSIST, Inc.
7117 N. 3rd Street
Phoenix, Arizona 85020
Phone: (602) 354-8491
FAX: (602) 354-8696
E-Mail: info@mdassist.com

WEBSITE:
MD Assist, Inc.

4/06/07