SMG 1252.3

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 BIORESEARCH MONITORING

Effective Date: 07/08/2011

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1. DIVISION OF BIORESEARCH MONITORING (DKKWBA)

A. Enforces the Medical Device Amendments of 1976 and the Safe Medical Devices Acts of 1990 and 1992 and the Radiation Control for Health and Safety Act of 1972 as it relates to inspections, and shipping and receipt of investigational device products

B. Implements the Application Integrity Policy (AIP) with the Office of Device Evaluation integrity officer

C. Enforces promotion and advertising regulations for investigational devices

D. Manages and coordinates device bioresearch monitoring activities, establishes, analyzes, and decides on the final decision related to investigational findings, and issues administrative and regulatory actions related to BIMO activities

E. Plans, initiates, and coordinates clinical and non-clinical research inspections and investigations of sponsors/monitors, contract research organizations, institutional review boards, clinal investigators, and non-clinical laboratories. Reviews and evaluates good clinical practices (GCPs) or good laboratory practices (GLPs) to ensure compliance with regulations

F. Develops, interprets, and issues policy or guidance in response to specific requests from the clinical industry, sponsor/monitors, clinical investigators, institutional review boards, other Federal agencies, and the general public. Assists the Agency and other Centers in the development, review and revision of new and amended regulations related to good clinical practices (GCPs) and good laboratory practices (GLPs) related to non-clinical research

G. Develops, coordinates, reviews, and implements programs to ensure uniform interpretation and application of GCPs and GLPs

H. Serves as a member of the application review teams by participating in pre-IDE and pre-PMA, PDP, filing and day-100 meetings; facilitates necessary ODE/field interactions

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	04/02/2008	N/a	OC/OO/ OM/OMP	Daniel G. Schultz, M.D., Director, CDRH
Revision	07/08/2011	N/a	CDRH/OMO	Secretary of Health and Human Services