SMG 1255.6

FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS

FOOD AND DRUG ADMINISTRATION

OFFICE OF MEDICAL PRODUCTS AND TOBACCO

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

OFFICE OF COMMUNICATION, EDUCATION AND RADIATION PROGRAMS

DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAM

Effective Date: 07/08/2011

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1. DIVISION OF MAMMOGRAPHY QUALITY AND RADIATION PROGRAMS (DKKWGC)

A. Develops, revises, and interprets standards and regulations for mammography facilities and their equipment, personnel and procedures, as well as for organizations approved to accredit mammography facilities, with the assistance of the National Mammography Quality Assurance Advisory Committee

B. Approves and annually evaluates bodies that accredit mammography facilities under the Mammography Quality Standards Act; establishes and maintains a system for the periodic certification and annual inspection of all mammography facilities; and develops and implements enforcement processes and procedures for facilities found to be out of compliance with the requirements of the Mammography Quality Standards Act

C. Establishes and maintains a program for the training, certification, and continuing education of Federal and State mammography facility inspectors

D. Develops and maintains mechanisms for ongoing liaison and routine communication with Federal, State and local government agencies, with relevant health professional and consumer groups, and with all certified mammography facilities about issues related to the Mammography Quality Standards Act and provides appropriate reports on the Mammography Quality Standards Act to the Department, Congress, and the public

E. Develops and implements techniques and procedures to assess trends in exposure and image quality in diagnostic radiology and identifies and corrects problems through cooperative Federal and State programs

F. Enforces the Federal Food, Drug, and Cosmetic Act, Electronic Product radiation Control Section (Formerly know as the Radiation Control for Health and Safety Act of 1968), and the Medical Device Amendments of 1976, including the Safe Medical Devices Act of 1990 and 1992

G. Manages and coordinates activities associated with administrative and regulatory actions for radiation emitting electronic products

H. Develops, interprets, and issues policy guidance in response to specific requests from electronic products industries, trade associations, other Federal agencies, other countries, State agencies, and the general public

I. Develops, review, and revised new and amended regulations and standards for radiation emitting electronic products

J. Plans, initiates, coordinates, and conducts electronic product inspections and investigations of manufacturers and their products. Reviews and evaluates design, test, and product data and reports from manufacturers to ensure compliance with promulgated standards and regulations

K. Identifies the need for and directs the development of Compliance Policy Guides and programs to facilitate compliance by manufacturers of radiation emitting electronic products

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.

STATUS (I, R, C)	DATE APPROVED	LOCATION OF CHANGE HISTORY	CONTACT	APPROVING OFFICIAL
Initial	08/23/2004	N/a	OC/OO/ OM/OMP	Acting Associate Commissioner for Management
Revision	07/08/2011	N/a	CDRH/OMO	Secretary of Health and Human Services