No. 93-117 FOR IMMEDIATE RELEASE

Tel. 301/504-2240 (Friday, August 27, 1993)

NRC AND FDA SIGN

MEMORANDUM OF UNDERSTANDING

Dr. Ivan Selin, Chairman of the Nuclear Regulatory

Commission, and Dr. David A. Kessler, M.D., Commissioner of the

Food and Drug Administration, have signed a Memorandum of

Understanding which coordinates the regulation of medical

devices, drugs and biological products that use radioactive

materials under the jurisdiction of the NRC.

In stressing the importance of the memorandum, Chairman

Selin said: "Our aim in this action is to add to the protection

of the public. Both the NRC and the FDA have responsibility for

regulating medical devices and pharmaceuticals containing

radioactive materials. This memorandum is designed to foster

cooperation between our two agencies as well as to provide more

effective exchanges of information."

"Devices, drugs and biological products that use radioactive

materials can be important in medical treatments and can save

lives," Dr. Kessler said. "However, it is vital that they be

used safely."

The Food and Drug Administration is responsible for assuring

the safety, effectiveness and proper labeling of medical

products, i.e., drugs, devices and biologics. The Nuclear

Regulatory Commission is responsible for licensing and regulating

civilian nuclear facilities and materials and for conducting

research in support of the licensing and regulatory process.

Under the terms of the Memorandum of Understanding, the NRC

and the FDA will:

-- on request assist each other, to the fullest extent

possible, in the investigation of incidents or complaints

involving products of mutual regulatory concern;

-- exchange information with respect to investigations with

the purpose of providing expert technical assistance to either

agency and to assist either agency by reducing or eliminating any

duplication of effort;
-2-

-- to the extent practicable, share information concerning

new technology or methods under development or review, including

devices, drugs or other biologics for which regulations have not

yet been developed or which are related to the mission of the

other agency;

-- offer each other the opportunity to comment on

notifications to manufacturers, operators, licensees or patients

and to comment on regulations, regulatory guides or other

communications that refer to activities, policies or regulations

of the other agency; and

-- make the other agency aware of and, to the extent

possible, allow participation by a representative from the other

agency in any advisory committee which advises on issues covered

by the Memorandum of Understanding;

In addition, the NRC, on request, will promptly notify its

licensees and the Agreement States (states which, by agreement,

have assumed part of the NRC's regulatory authority) of any

public health issues or other important user communications

initiated by the FDA as the result of joint investigations or

other activities involving products of mutual regulatory concern.

The Memorandum of Understanding covers only those medical

devices, drugs and biological products using radioactive

materials regulated under the Atomic Energy Act of 1954, as

amended. The terms "drug" and "device" are defined in the

Federal Food, Drug, and Cosmetic Act, as amended, and a

"biological product" is either a drug or a device under the Act.

Biological products are also regulated under the Public Health

Service Act.

Medical devices affected include, but are not limited to:

in vitro diagnostic kits (radioimmunoassay), teletherapy and

brachytherapy sources, systems and accessory devices. Biologics

include, but are not limited to: licensed in vitro diagnostic

kits (radioimmunoassay) and certain radiolabeled biologics for in

vivo use. Drugs include all those that contain radioactive

materials derived from the operation of reactors (byproduct

material).

#