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U.S. Department of Health and Human Services

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SMG 1253.6

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 DEVICE EVALUATION

DIVISION OF REPRODUCTIVE, GASTRO-RENAL AND UROLOGICAL DEVICES

Effective Date: 07/08/2011

[PDF Version]

1. DIVISION OF REPRODUCTIVE, GASTRO-RENAL AND UROLOGICAL DEVICES (DKKWCB)

A. Serves as the primary source for scientific and medical expertise on reproductive, urology and gastroenterology devices with regard to safety and effectiveness

B. Performs, coordinates, directs and monitors all actions including scientific and medical review and evaluation for documents related to classification, petitions, premarket notification submissions (510(k)s), premarket approval applications (PMAs), product development protocols (PDPs), and investigational device exemptions (IDEs), and supplements or amendments to these submissions

C. Makes equivalence and nonequivalence determinations; approves or disapproves actions related to classification, petitions, 510(k)s, PMAs, PDPs, and IDEs and all supplements and amendments to these submissions, as authorized

D. Provides executive secretarial support and other technical and nontechnical support to device advisory panels and panel members and consultants, and takes action on panel recommendations

E. Provides liaison, coordinates and takes action, as appropriate, on classification actions, petitions, 510(k)s, PMAs, PDPs, and IDEs with Center and Agency components; Federal, State, and international agencies; and industry, consumer, and professional organizations

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
Initial01/12/2010N/aOC/OA/
OM/OMP
Commissioner of Food and Drugs
Revision07/08/2011N/aCDRH/OMOSecretary of Health
and Human Services