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SMG 1253.7

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 SURGICAL, ORTHOPEDIC AND RESTORATIVE DEVICES

Effective Date: 07/08/2011

[PDF Version]

 1. Division of Surgical, Orthopedic and Restorative Devices
 2. General Surgery Devices Branch
 3. Restorative Devices Branch
 4. Plastic and Reconstructive Surgery Devices Branch
 5. Orthopedic Joint Devices Branch
 6. Orthopedic Spine Devices Branch
 7. Authority and Effective Date

1. DIVISION OF SURGICAL, ORTHOPEDIC AND RESTORATIVE DEVICES (DKKWCC)

A. Serves as the primary source for scientific and medical expertise on general surgery, plastic and reconstructive surgery, orthopedic and restorative 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. GENERAL SURGERY DEVICES BRANCH (DKKWCC1)

A. Serves as the primary source for scientific and medical expertise on general surgery 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

3. RESTORATIVE DEVICES BRANCH (DKKWCC2)

A. Serves as the primary source for scientific and medical expertise on restorative 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

4. PLASTIC AND RECONSTRUCTIVE SURGERY DEVICES BRANCH (DKKWCC3)

A. Serves as the primary source for scientific and medical expertise on plastic and reconstructive surgery 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

5. ORTHOPEDIC JOINT DEVICES BRANCH (DKKWCC4)

A. Serves as the primary source for scientific and medical expertise on orthopedic joint 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

6. ORTHOPEDIC SPINE DEVICES BRANCH (DKKWCC5)

A. Serves as the primary source for scientific and medical expertise on orthopedic spine 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

7. 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
Initial12/23/2008N/aOC/OO/
OM/OMP
Daniel Schultz, M.D., Director, CDRH
Revision07/08/2011N/aCDRH/OMOSecretary of Health
and Human Services