SMG 1254.10

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 IMAGING AND APPLIED MATHEMATICS

Effective Date: 07/08/2011

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1. DIVISION OF IMAGING AND APPLIED MATHEMATICS (DKKWED)

A. Participates in the Center's mission in a variety of ways including conducting research, 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 medical imaging and applied mathematics

B. Provides scientific expertise and carries out a program of applied research in support of CDRH regulation of radiation-emitting products, medical: imaging systems, and other devices utilizing computer-assisted diagnostic technologies. Medical imaging research encompasses ionizing and nonionizing radiation from data capture through image display and observer performance

C. The computer-assisted diagnostics work is focused on the appropriate mathematical evaluation methodologies for sophisticated computational algorithms used to aid medical practitioners interpret diagnostic device results

D. Develops and disseminating performance assessment methodology appropriate to these modalities

E. Operates a calibration laboratory for ionizing radiation

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