Qualifications

Since August 1995, I, Suzanne Parisian, M.D. have been President and founder of Medical Device Assistance, Inc., a regulatory and medical consulting firm specializing in matters involving the United States Food and Drug Administration's regulation of medical products.

I received my Medical Degree (M.D) from the University of South Florida in 1978 and am Board Certified in Anatomic and Clinical Pathology.

From 1991 to 1995, I served as a Commissioned Officer in the United States Public Health Service and achieved the rank of Commander. During this time period, I was primarily assigned to the Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA).

Concurrently, during l991 to l995, I was also assigned clinical responsibilities at the Armed Forces Institute of Pathology (AFIP), Office of the Medical Examiner for the Armed Forces, Washington, D.C.

From 1991 to 1993, I was a Medical Officer in the Office of Health Affairs (OHA) a staff office within the FDA.

From March 1993 to December 1993, I was a Medical Officer in the Office of Device Evaluation, (ODE), Division of Reproductive Abdominal, Ear, Nose and Throat, and Radiology, (DRAERD) at the FDA.

From January 1994 through June 1995, I was Chief Medical Officer for DRAERD at the FDA.

My most current curriculum vitae is provided in Attachment "1" (http://www.mdassist.com).

ODE, FDA is the Office within CDRH responsible for the premarketing evaluation of product applications submitted by the manufacturer to market devices that are safe and effective within the United States.

In ODE, I participated in the review of marketing applications as well as had the assigned responsibility of training new medical officers and scientific reviewers in application and labeling review at CDRH.

I was an instructor in FDA’s Staff College for the instruction of CDRH reviewers in the design and evaluation of clinical data contained within 2 premarketing applications.

While in OHA, I was a medical officer responsible for the review of mandatory adverse event reports submitted by a manufacturer, as well as the review of voluntary reports submitted by health care providers, patients and others.

Within OHA, I was the primary clinician assigned responsibility to preside over 162 health risk assessments that were convened to advise FDA on the:

· overall health risk of medical devices’

· performance issues,

· identification of public health safety issues,

and to make recommendations to FDA regarding the subsequent regulatory actions that should be undertaken by FDA, health care providers, users groups and manufacturers in order to help protect the public’s welfare.

While in ODE, I performed an additional 100 health risk assessments and trained medical officers as to the procedure for conducting a health risk assessment.

At FDA, I participated with FDA’s District Offices, Office of General Consul, and the Office of Compliance in the review of manufacturing records, product complaints and adverse event reports obtained by FDA.

I was the primary clinician involved in several of FDA’s Major Corporate-Wide actions for which I received various citations and honors for my services from FDA, including Department of Health and Human Services and the Federal Government Employee of the Month.

I was sent by FDA as official Agency representative to medical meetings and seminars to help monitor medical device manufacturers and distributors for deviations from regulations governing promotional activities.

I was also required to provide guidance as to the FDA’s interpretation of Food and Drug Laws as they pertain to medical products and the role of manufacturers.

After leaving FDA, and founding Medical Device Assistance, Inc., I have continued to provide information to individuals and organizations outside FDA regarding FDA’s requirements, Adverse Event Reporting, and labeling of medical products. I was requested by FDA to participate in a l997 panel of experts convened by FDA to comment on changes proposed in the requirements for medical device labeling.

I continue to lecture at conferences and seminars regarding FDA, premarket clearance, design of clinical trials and product labeling. I am the author of FDA Inside and Out published May 2001 which is a book about the workings and history of the FDA.

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