SMG 1253.1

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

OFFICE OF DEVICE EVALUATION

Effective Date: 07/08/2011

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1. OFFICE OF DEVICE EVALUATION (DKKWC)

A. Advises the Center Director and other agency officials on all premarket notification submissions (510(k)s), premarket approval applications (PMAAs), product development protocols (PDPs), device classifications, and investigational device exemptions (IDEs)

B. Plans, conducts, and coordinates appropriate Center actions regarding approval, denial, and withdrawal of approval of PMAAs, PDPs, IDEs, and makes substantially equivalent determinations for 510(k)s, and monitors sponsors' conformance with requirements of all programs

C. Conducts a continuing review, surveillance, and medical evaluation of the labeling, clinical experience, and required reports submitted by sponsors of approval applications

D. Provides executive secretariat and other technical support to medical device advisory panels; recommends establishing or restructuring such panels as appropriate

E. Develops and interprets regulation and guidelines regarding classification, PDPs, IDEs, PMAAs, and 510(k)s

F. Coordinates Center classification activities; reviews petitions for or initiates reclassification of medical devices

G. Participates in the development of national and international consensus standards, and voluntary guidelines through interaction with appropriate national and international standards committees

H. Operates a document control system

2. AUTHORITY AND EFFECTIVE DATE

The functional statements for this Office 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	12/23/2008	N/a	OC/OO/ OM/OMP	Daniel Schultz, M.D., Director, CDRH
Revision	01/12/2010	N/a	OC/OA/ OM/OMP	Commissioner of Food and Drugs
Revision	07/08/2011	N/a	CDRH/OMO	Secretary of Health and Human Services