SMG 1252.4

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 COMPLIANCE

DIVISION OF RISK MANAGEMENT OPERATIONS

Effective Date: 07/08/2011

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1. DIVISION OF RISK MANAGEMENT OPERATIONS (DKKWBB)

A. Advises and supports Office officials and staff regarding all policies and procedures relating to administrative support activities

B. Provides analysis activities for Office, Center and Agency senior management in the development and implementation of risk-base regulatory and enforcement activities

C. Advises Office officials and staff regarding management information systems initiatives and serves as the Office liaison to other Center and Agency components on such matters. Plans, coordinates, and implements an Office Information Technology strategic plan

D. Provides information for requests from external as well as internal sources. Coordinates and processes Freedom of Information (FOI) requests and issues certificates for requests to export approved medical devices and non-approved medical devices under 801(e) of the Federal Food, Drug, and Cosmetic Act

E. Coordinates the Centers administrative activities with field offices as well as internal regulatory actions. Provides information to Office and Center senior staff in order to guide and direct field management in inspectional priorities

F. Develops, coordinates, and/or conducts medical devices and electronic products training programs for field personnel and state and local agencies in coordination with other Center and Agency components

G. Develops, processes information for, and maintains the medical device registration and product listing system; develops and monitors contracts for data processing; ensures industry compliance with reporting requirements through a certification program; and develops and maintains a document tracking system

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	08/04/2004	N/a	CDRH/OMO	Director, Center for Devices and Radiological Health
Revision	07/08/2011	N/a	CDRH/OMO	Secretary of Health and Human Services