• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

SMG 1253.9

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 OPTHALMIC, NEUROLOGICAL AND EAR, NOSE, AND THROAT DEVICES

Effective Date: 07/08/2011

[PDF Version]

 1. Division of Opthalmic, Neurological and Ear, Nose, and Throat Devices
 2. Intraocular, Corneal and Neuromaterials Devices Branch
 3. Opthalmic Lasers, Neuromuscular Stimulators and Diagnostics Devices Branch
 4. Neurodiagnostic and Neurotherapeutic Devices Branch
 5. Ear, Nose, and Throat Devices Branch
 6. Authority and Effective Date

1. DIVISION OF OPTHALMIC, NEUROLOGICAL AND EAR, NOSE, AND THROAT DEVICES (DKKWCE)

A. Serves as the primary source for scientific and medical expertise on ophthalmic, neurological and ear, nose, and throat devices with regard to safety and effectiveness

B. Performs, coordinates, directs and/or 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 non-equivalence 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 classification 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. INTRAOCULAR, CORNEAL AND NEUROMATERIALS DEVICES BRANCH (DKKWCE1)

A. Serves as the primary source for scientific and medical expertise on intraocular, corneal and neuromaterials devices with regard to safety and effectiveness

B. Performs, coordinates, directs and/or 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 non-equivalence 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 classification 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. OPHTHALMIC LASERS, NEUROMUSCULAR STIMULATORS AND DIAGNOSITCS DEVICES BRANCH (DKKWCE3)

A. Serves as the primary source for scientific and medical expertise on ophthalmic lasers, neuromuscular stimulators and diagnostics devices with regard to safety and effectiveness

B. Performs, coordinates, directs and/or 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 non-equivalence 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 classification 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. NEURODIAGNOSTIC AND NEUROTHERAPEUTIC DEVICES BRANCH (DKKWCE4)

A. Serves as the primary source for scientific and medical expertise on neurodiagnostic and neurotherapeutic devices with regard to safety and effectiveness

B. Performs, coordinates, directs and/or 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 non-equivalence 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 classification 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. EAR, NOSE, AND THROAT DEVICES BRANCH (DKKWCE5)

A. Serves as the primary source for scientific and medical expertise on ear, nose, and throat devices with regard to safety and effectiveness

B. Performs, coordinates, directs and/or 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 non-equivalence 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 classification 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. 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