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U.S. Department of Health and Human Services

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SMG 1250.1

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

Effective Date: 07/08/2011

[PDF Version]

1. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (DKKW)

A. Develops and carries out a national program designed to control unnecessary exposures of humans to, and assure the safe and efficacious use of, ionizing and nonionizing radiation-emitting electronic products

B. Develops and carries out a national program to assure the safety, effectiveness, and labeling of medical devices for human use

C. Plans, conducts, and supports research and testing to provide the scientific and technological base required for risk assessment, evaluation, compliance, and performance standards development relating to medical devices and radiation-emitting electronic products

D. Collects information about inquiries and other experience in the use of medical devices and radiation-emitting electronic products and uses this information in Center activities

E. Reviews and evaluates medical device premarket approval applications (PMAAs), product development protocols (PDPs), exemption requests for investigational devices (IDEs), and premarket notifications (510(k)s)

F. Develops, promulgates, and enforces performance standards for radiation-emitting electronic products and medical devices, and Good Manufacturing Practice (GMP) regulations

G. Develops, directs, evaluates, and monitors compliance and surveillance programs for medical devices and radiation-emitting electronic products

H. Provides technical and other nonfinancial assistance to small manufacturers of medical devices

I. Develops and implements training and educational programs relating to radiological health and medical device issues for other Federal, State, and local agencies, the professional community, consumers, and the public

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Center 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 07/08/2011 N/a OO/OM Secretary of Health
and Human Services
Change 07/08/2011 N/a CDRH/OMO Secretary of Health
and Human Services

 

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