SMG 1256.2

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 SURVEILLANCE AND BIOMETRICS

DIVISION OF BIOSTATISTICS

Effective Date: 07/08/2011

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1. DIVISION OF BIOSTATISTICS (DKKWHA)

A. Critically reviews materials submitted to or generated by the Center including IDE, PMA, 510(k) applications, standards and guidelines for statistical validity and consistency

B. Conducts original statistical research and modeling studies and collaborates in the design, analysis, and interpretation of laboratory and epidemiologic studies on the health effects of medical device use and exposure to radiation

C. Provides comprehensive statistical computational support to internal and external Center activities including collaborative design, analysis, and participation in the standards and compliance activities

D. Performs risk assessments and risk/benefit analyses for medical device and radiation programs and participates with other Center components in regulatory, and educational activities

E. Collaborates with statisticians in other Centers and Agencies on matters of mutual interest including methodological issues and statistical research

F. Interacts with national, international, public and private organizations to identify common statistical problems and areas of mutual interest associated with the regulation of medical devices and 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	07/08/2011	N/a	CDRH/OMO	Secretary of the Department of Health and Human Services