SMG 1254.6

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 SCIENCE AND ENGINEERING LABORATORIES

DIVISION OF ELECTRICAL AND SOFTWARE ENGINEERING

Effective Date: 07/08/2011

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1. DIVISION OF ELECTRICAL AND SOFTWARE ENGINEERING (DKKWEG)

A. Participates in the Center's mission in a variety of ways including conducting research, participating in device review activities, developing consensus standards both domestic and international, developing regulatory guidance, testing forensic and regulatory samples, and providing educational programs in the area of electrical engineering and software

B. Works in the application of electronics, software engineering, and systems engineering body of knowledge to the regulation of medical devices and electronic products that emit radiation

C. Addresses the cutting edge of medical devices through all phases of the product life cycle and all aspects of the product manufacturer's business, from research and development through procurement, production, and ongoing customer support

D. Capabilities include analog and digital circuit design, data acquisition and display, embedded microprocessor and PC-based systems, software-based virtual instruments, quality management and risk management as applicable to electronics and software, testing for hazards arising from the use of electrical and electronic technology in medical products, and electronic design including components, circuits, and analytical techniques for controlling high voltages and/or currents

E. Staff members are primarily electronics engineers, physicists, biomedical engineers, and general engineers

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	02/19/2004	N/a	OC/OO/ OM/OMP	Center Director, CDRH
Revision	07/08/2011	N/a	CDRH/OMO	Secretary of Health and Human Services