Memorandum of Understanding
The Department of Defense
The Food and Drug Administration
To formalize a memorandum of understanding (MOU) between the Department of Defense (DoD) and the Food and Drug Administration (FDA) whereby FDA provides the quality assurance support for DoD centrally managed contracts for drugs, biologics, and medical devices (hereinafter referred to as medical products), as defined by the Federal Food, Drug and Cosmetic Act (FDC Act), as amended, 21 U.S.C.A. 301 et seq. (1972 & Supp. 1979). This agreement supersedes the two currently effective agreements, the drug agreement dated 12/17/75 and the device agreement dated 12/23/81.
The Office of Management and Budget (OMB) and the General Accounting Office (GAO) completed separate studies in late 1973 of nonperishable subsistence supplies. Both OMB and GAO recommended that the FDA be the agency responsible for quality assurance of all medical products procured by Federal agenies. In June 1974, the Director of OMB requested the Department of Health, Education and Welfare (HEW) take the lead in developing an Executive Branch Plan for the government-wide quality assurance program for medical products. FDA was made responsible for developing and implementing the plan. In December 1975, FDA and DoD signed a quality assurance agreement covering drugs and biologics, and in December 1981, a corresponding agreement covering medical devices was signed. Both agreements were implemented and have been operational. However, some portions of the original agreements have become obsolete and there is a need to encompass new DoD initiatives and business practices. This updated memorandum of understanding encompasses all medical products under FDA regulatory control, and supersedes the two currently effective interagency agreements.
A. Under the authority of DoD Directive 4140.26, the Defense Personnel Support Center (DPSC) is assigned and designated as the integrated manager for medical products. The DPSC agrees to:
(1.) Furnish FDA copies of medical product quality complaints, incident reports under the Safe Medical Device Act of 1990, and other information which may impact adversely on the quality of a medical product.
(2.) Provide a written request for evaluations, testing, and other work to be performed by FDA under this program.
(3.) Furnish FDA copies of specifications for review, solicitations and copies of contracts requiring FDA source inspection.
(4.) Notify the FDA liaison officer in writing of changes in acquisition regulations and practices which would affect the program covered by this MOU.
B. The Food and Drug Administration (FDA) agrees to:
(1.) Furnish DPSC reports of complaint investigations.
(2.) Upon request, provide pre-award quality evaluations for firms.
(3.) Promptly advise DPSC when firms supplying medical products to DoD become unacceptable from a quality assurance standpoint.
(4.) Determine the amount and nature of work it will perform to fulfill its responsibilities under this MOU.
(5.) Make available FDA inspectional and analytical personnel as witnesses and supply information and data to DoD for GAO protests, Boards of Contract Appeals, SBA and similar cases.
(6.) Review proposed specifications and provide comments on the quality assurance aspects.
(7.) Notify the DPSC liaison officer in writing of changes arising from statutes or regulations which would affect this program.
(8.) Promptly notify DPSC of product recalls and other pertinent information that affects government contracts or stocks.
(9.) Advise DPSC of instances where fraud or other criminal conduct involving government contractors is found.
(10.) Be responsible for determining that medical products offered for delivery were produced in accordance with the contract requirements, and for signing the acceptance document when source inspection is required.
(11.) Conduct laboratory testing as necessary and, as expeditiously as possible, furnish DPSC analytical results. If testing cannot be accomplished, FDA will notify DPSC.
(12.) Advise DPSC when FDA determines that it is necessary to convert a contract form destination to source inspection.
A. Resources required to support this MOU will be provided by the performing party.
B. Nothing in this MOU will preclude DoD representatives from making visits to suppliers with FDA or separately.
C. The DPSC contracts for medical products will include a provision requiring compliance with the FDC and implementing regulations promulgated thereunder. The Good Manufacturing Practice Regulations will be the quality standard applied to industry for the manufacturing, processing, packaging or holding of medical products acquired on government contracts. The FDA will be the agency responsible for the administrative interpretation and enforcement of these statutes and regulations.
D. The DPSC may authorize the FDA to act as its agent for purposes of inspecting and accepting centrally acquired medical products, performance of preward surveys, and related quality assurance actions.
E. As a general rule, the quality standards prescribed by the United States Pharmacopeia (USP), the National Formulary (NF), and FDA will satisfy the DoD quality requirements for products covered by the MOU; however, this does not preclude the development and utilization by DoD of additional standards when deemed essential to satisfy a unique or special requirement of DoD or any of the Military Services.
F. The FDA and DPSC, as necessary, will jointly prepare procedures covering operations that interface.
V. PARTICIPATING ACTIVITY LIAISON OFFICERS
A. For the Department of Defense:
Director, Medical Material, DPSC-M, Defense Personnel Support Center, Defense Logistics Agency, 2800 South 20th Street, Philadelphia, Pennsylvania 19101-8419, (215) 737-2100.
B. For the Food and Drug Administration:
Director, Medical Products Quality Assurance Staff, HFC-240, Office of Regulatory Affairs, Food and Drug Administration, 12720 Twinbrook Parkway, Bldg. #4, Room 408, Rockville, Maryland 20852, (301) 827-0390.
VI. PERIOD OF MEMORANDUM OF UNDERSTANDING
a. This MOU will become effective upon final signature and will remain in effect indefinitely.
b. The MOU will be reviewed every two (2) years to ensure adequacy and currency; however, it may be amended by mutual consent at any time.
c. The MOU may be unilaterally terminated by providing the other party with 180 days written notice of intent.
Approved and Accepted
Signed by: Edward D. Martin, M.D.
Date: January 14, 1997
Approved and Accepted
Signed by: M.A. Friedman
Date: November 27, 1996