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U.S. Department of Health and Human Services

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SMG 1254.5

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 SOLID AND FLUID MECHANICS

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF SOLID AND FLUID MECHANICS (DKKWEF)

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 solid and fluid mechanics

B. Core responsibilities involve issues for which mechanical interactions or transport are of primary concern, such as those involving motion; structural support, stabilization, or vibrations; device and material mechanical integrity; materials durability; and biologically relevant parameters of device and materials. The division has expertise in the areas of fluid dynamics, solid mechanics and materials, acoustics and ultrasonics

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

D. Evaluates interactions of ultrasound energy with matter and the implications of these interactions on the safety and effectiveness of devices and products. Technical disciplines of the Division's staff include mechanical engineering, materials science, biomedical engineering, general engineering, and physics

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 APPROVEDLOCATION
OF CHANGE HISTORY		CONTACTAPPROVING OFFICIAL
Initial02/19/2004N/aOC/OO/
OM/OMP		Center Director, CDRH
Revision07/08/2011N/aCDRH/OMOSecretary of Health
and Human Services

 

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