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MOU number: 225-75-5011

Memorandum of Understanding

Between
The Veterans Administration

and

The Food and Drug Administration

The Veterans Administration (hereinafter called VA) and the Food and Drug Administration (hereinafter called FDA) hereby jointly agree to the terms and conditions as described herein.

Purpose: To establish procedures for exchanging medical device experience data.

Background

The VA and FDA have a mutual responsibility to the patient for assuring that medical devices and diagnostic products are safe, efficacious and that the health community is advised of any unsafe or ineffective devices or diagnostics. To carry out this responsibility, the VA and FDA agree that it would be mutually beneficial to utilize their respective information systems by coordinating reports of medical device and diagnostic product experiences. The VA can provide the FDA with medical device experience data from its hospital system. In addition, VA can provide technical expertise in the identification and resolution of medical device and diagnostic product problems.

This information will be of great value in the identification of health and safety hazards, the collection of historical data for trend analysis and the exchange of general data to benefit patient care and the health community.

I. Definition of Work

A telephone and teletype link will be established between the VA Marketing Center at Hines, Illinois, and the FDA/Bureau of Medical Devices and Diagnostic Products, Rockville, Maryland. The VA's Department of Data Management will work as a liaison with FDA/BMDDP in establishing this communications link. This system will be used by both parties for the transmission of data concerning medical device and diagnostic product problems, especially those requiring immediate investigations, warnings, or recalls. This exchange of information will also serve as a base upon which future working relationships can be built.

FDA and VA at a time designated by the VA, will develop and conduct an education and awareness program intended to acquaint VA health personnel with the opportunity to report, and the procedures for reporting, medical device and diagnostic product problems encountered in the VA hospital system.

Subsequent to the establishment of the communications interface, the VA and FDA will develop and pilot test the concept of a project manager; where selected VA hospital personnel are identified and assigned responsibility for the identification, generation, and transmission to FDA of medical device and diagnostic product problems encountered at their respective stations.

The VA will review its reporting procedures which involve product malfunctions, patient incidents, safety hazards, product defects, and other related matters. The objective of this review is to develop improved procedures for identifying and collecting product problem experience data within the VA, thereby facilitating exchange of information between the two parties.

The VA and FDA will share any cost(s) involved in establishing a communications interface. Each agency will also absorb its respective transmission and personnel costs.

To insure proper coordination between the two agencies, the on-going liaison responsibility for these programs will be assigned to the Director, Bureau of Medical Devices and Diagnostic Products (FDA), and the VA's Chief Medical Director, or designees. Once the system is established, the Director, Supply Service or Manager, VA Marketing Center, as appropriate, will serve as the liaison with FDA/BMDDP. Conversely, the Director, Bureau of Medical Devices and Diagnostic Products, or designee, will serve as liaison with the VA.

II. Name and Address of Participating Agencies

Veterans Administration
Department of Medicine & Surgery
Washington, D.C. 20420

Food and Drug Administration
Bureau of Medical Devices and Diagnostic Products
5600 Fishers Lane
Rockville, Maryland 20852

III. Liaison Officers

A. Mr. Donald P. Whitworth
Director, Supply Service
Department of Medicine & Surgery
The Veterans Administration
Washington, D.C. 20420
Telephone: (202) 389-2314

B. Mr. Chester T. Reynolds
Division of Compliance (HFK-100)
Bureau of Medical Devices & Diagnostic Products
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20852
Telephone: (301) 443-4627

IV. Period of Agreement

This agreement, when accepted by both parties, covers an indefinite period of time, and may be modified by mutual consent of both parties or terminated by either party upon a thirty (30) day advance written notice to the other.

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