SMG 1254.9

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 PHYSICS

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF PHYSICS (DKKWEC)

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 physics

B. Conducts research and engineering studies to support the Center's mission to assure the safety and effectiveness, and promote the improvement of medical devices and electronic products

C. Scientific and technical specialties in the division include optical physics and metrology sensors, fiber optics, electromagnetic, electromagnetic compatibility and electromagnetic interference, electrophysics and electrical stimulation technologies electrophysiology, radiofrequency/microwave metrology, and minimally invasive optical and electromagnetic technologies

D. Develops measurement methods instrument calibration capabilities and analytical procedures to characterize and evaluate devices and products, and supports the Center's enforcement and product testing activities

E. Evaluates interactions of electromagnetic and optical energy with matter, analyzes implications for the safety and effectiveness of devices and products and develops and evaluates procedures for minimizing or optimizing human exposure from such devices

F. The technical disciplines of the staff include physics, mathematics, biophysics biomedical engineering, electronics, and general engineering

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