Contents

SUBCHAPTER 240 - CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

240 - OFFICE OF THE CENTER DIRECTOR

David Feigal, MD is the Center Director of CDRH. Linda Kahan is the Deputy Center Director of CDRH. Lillian J. Gill is the Senior Associate Director of CDRH.

The Center for Devices and Radiological Health (CDRH) develops and carries out a national program to assure the safety, effectiveness, and labeling of medical devices for human use. It reviews and evaluates medical device pre-market approval applications (PMA's), product development protocols (PDP's), exemption requests for investigational devices (IDE's), and premarket notifications [510(k)'s].

The Center provides technical and other nonfinancial assistance to small manufacturers of medical devices.

CDRH develops and carries out a national program designed to control unnecessary exposures of humans to, and assure the safe and efficacious use of, ionizing and non-ionizing radiation-emitting electronic products.

CDRH has about 1000 employees.

The Office of the Center Director, in addition to providing overall leadership and direction for the Center, provides advice and consultation to the Commissioner and other Agency officials on policy matters concerning radiological health and medical device activities. The office recommends changes in legislative authority to the Commissioner, establishes policy in the areas of education and communications, and formulates strategies for developing and disseminating educational and programmatic information to health professionals, consumers, and other government agencies. The office plans and coordinates the Center's equal employment opportunity programs.

241 - OFFICE OF SYSTEMS AND MANAGEMENT (HFZ-2) RUTH CLEMENTS, DIRECTOR

The Office of Systems and Management (OSM) advises the Center Director on all administrative and management matters, and plans, develops and implements Center management policies and programs concerning such areas as manpower and financial management, personnel management, contracts and grants. OSM also develops and applies evaluation techniques to measure the effectiveness of Center programs, and provides general information and technical publications support to the Center. Other functions include planning and coordinating all of the Center's scientific advisory committee management activities.

OSM also determines and implements Center strategy and utilization of information management resources. OSM designs administrative and scientific technical information systems in support of Center programs, designs and conducts educational programs for Center employees in data processing and management, and provides assistance to Center staff in accessing information necessary to carry out the Center's mission.

OSM is also responsible for carrying out the Center's FOI activities.

The Office of Systems and Management is comprised of the following:

1. Integrity, Committee and Conference Management Staff - Communicates and coordinates ethics issues, FMFIA, committee management activities, serves as the Center's Intramural Research Integrity Officer, conference management program.
2. Division of Management Operations - Provides advice and guidance to Center management on personnel, procurement, property, facilities, occupational health and safety. Implements Center management policies and/or programs.
3. Division of Planning, Analysis and Finance - Develops and justifies budget, manages budget, develops and implements long-range and strategic planning, conducts evaluations, impact studies and research studies, and implements administrative policies for extramural research programs.
4. Division of Information Dissemination - Provides information dissemination services to Center and the public, develops and manages library science strategies and systems, provides advice, guidance and technical support to program officials on FOIA.
5. Division of Information Technology Management - Develops and implements information management strategies and policies, maintains ADP security plan, trains Center personnel and provides user assistance.
6. Program Management Staff - Provides administrative functions and computer support to the Office of Systems and Management.

242 - OFFICE OF SCIENCE AND TECHNOLOGY (HFZ-100) LARRY KESSLER, Sc.D., DIRECTOR

The Office of Science and Technology (OST) provides scientific and laboratory support in response to program needs of other Center and Agency components. OST plans, develops, and implements Center research and testing programs, and protocols in the areas of physical science, life science, and engineering. OST develops, modifies, and calibrates scientific instruments and equipment for use in testing programs; plans, conducts or stimulates research on the human health effects of radiation and medical devices and provides scientific and engineering support for the review of medical devices and radiological product submissions. OST conducts research related to existing and emerging health technologies.

OST provides leadership and technical expertise to other Departmental components in applying health physics procedures and radiation protection principles to radiological emergencies and other public radiation instances, and provides technical services and health physics advice to the Center.

OST also conducts studies to assess or advance the practical application of radiation protection principles, and maintains liaison with national and international radiation protection organizations.

There are 5 divisions in the OST as follows:

1. Division of Management, Information and Support Services - Provides the following services for the office: administrative support, fabrication and engineering support, technical information and reading room information.
2. Division of Electronics & Computer Science - Provides electronics, engineering and imaging and computer science support for Center programs.
3. Division of Mechanics and Material Science - Develops and provides technical support for measurement methods and analytical procedures, conducts and/or supports research studies for safety thresholds, provides support to the device evaluation process.
4. Division of Physical Sciences - Plans and conducts laboratory and program activities in the physical science s and general engineering disciplines.
5. Division of Life Sciences - Plans, conducts, supports and evaluates research on the health effects of radiation and medical devices.

243 - OFFICE OF HEALTH AND INDUSTRY PROGRAMS, (HFZ-200) LIREKA P. JOSEPH, Ph.D., DIRECTOR

The Office of Health and Industry Programs (OHIP) conducts and evaluates nationwide programs to prevent injuries and deaths resulting from misuse of medical devices. It applies Special Controls authorities specified in the Safe Medical Devices Act of 1990, as a means of assuring safe and effective use of medical devices. OHIP performs in-depth analyses of medical device adverse incident reports, often with the assistance of representatives of relevant health professional, manufacturer and consumer organizations. OHIP conducts and coordinates informational and training activities for these groups; provides training services to the Agency, and other federal, state and foreign government agencies and health-related missions; and participates in the development of national and international consensus standards and voluntary guidelines. In addition, OHIP establishes and maintains liaison with consumer and professional organizations, industry associations and groups, and foreign and domestic governmental organizations to promote Center program goals.

Other functions include coordinating the Center's cooperative activities with foreign government counterparts and international health organizations.

OHIP is the focal point for liaison with the Office of General Counsel and appropriate Agency components on FDA regulation development responsibilities relating to medical device and radiological health activities.

Provides expertise in communications technology in support of Center & FDA programs and the Staff College functions.

Staff College - Develops training courses for Center, sponsors seminars and lectures, performs needs assessments and develops training objectives.

Regulations Staff - Advises Center and Agency officials on FDA regulation development responsibilities.

Program Operations Staff - Provides administrative and computer support to the office, serves as the Center Consumer Affairs representative.

Division of Small Manufacturers, International and Consumer Assistance (DSMICA) - Provides technical and other non-financial assistance to small manufacturers.

Division of Device User Programs and Systems Analysis - Participates in the postmarket problem analysis and solution strategy activities, such as labeling and human factors guidance, to ensure user-related issues are addressed.

Division of Communication Media - Provides and maintains expertise in communications technology services and coordinates media and graphic arts services to the Center, FDA, and other Government agencies.

Division of Mammography Quality and Radiation Programs - Responsible for implementing the Mammography Quality Standards Act of 1992 and provides program planning and support activities for cooperative programs with other agencies which have radiological health responsibilities. Provides education and communication to mammography facilities and parties interested in mammography quality.

244 - OFFICE OF COMPLIANCE (HFZ-300) TIM ULATOWSKI, DIRECTOR

The Office of Compliance (OC) develops, directs, coordinates, evaluates, and monitors compliance programs covering regulated industry. OC conducts electronic product field tests and inspections when necessary for regulatory purposes, and evaluates industry quality control and testing programs to assure compliance with regulations. OC provides advice to Agency field offices on, and manages Center activities relating to, legal actions, case development, and contested case assistance. OC coordinates field planning activities and issues all field assignments for the Center.

The Office of Compliance has five divisions as follows:

1. Division of Program Operations - Administrative functions for the office; clearinghouse for all assignments issued by the Center to the field; processing of Compliance Programs, Compliance Policy Guides; registration and listing program; certificates for export products.
2. Division Bioresearch Monitoring - Manages and coordinates the administrative and regulatory responsibilities of the Agency's Bioresearch Monitoring Program for medical devices.
   The Enforcement divisions were created along product lines as follows:
3. Division of Enforcement I - in vitro diagnostics, diagnostics devices and general surgery devices
4. Division of Enforcement II - dental, ear, nose and throat; ophthalmic; urology, gastroenterology, general hospital, and obstetrics/gynecology.
5. Division of Enforcement III - cardiovascular and neurology devices; orthopedic, physical medicine, and anesthesiology devices; therapeutic radiographic devices and electronic products.

245 - OFFICE OF DEVICE EVALUATION (HFZ-400), DANIEL SCHULTZ, M.D., Ph.D. , DIRECTOR

The Office of Device Evaluation (ODE) plans, conducts, and coordinates appropriate Center actions regarding approval, denial, and withdrawal of approval of pre-market approval applications (PMA's), product development protocols (PDP's), and investigational device exemptions (IDE's). ODE makes substantially equivalent determinations for pre-market notification submissions [510(k)'s]; and monitors sponsors' conformance with requirements of all programs. ODE also coordinates Center Classification activities, reviews petitions for or initiates reclassification of medical devices, provides executive secretariat and other technical support to medical device advisory panels, and conducts continuing review, surveillance, and medical evaluation of the labeling clinical experience, and required reports submitted by sponsors of approved applications.

The Office of Device Evaluation is organized as follows:

1. Program Management Office - Provides administrative functions for the office.
2. Program Operations Staff - Advises Office officials on premarket approval application, investigational device exemptions, premarket notification activities and classification/reclassification activities.
   The Divisions serve as the primary source for scientific and medical device expertise with regard to safety and effectiveness.
3. Division of General, Restorative and Neurological Devices - general and restorative devices and neurological devices.
4. Division of Clinical Laboratory Devices-clinical laboratory devices.
5. Division of Cardiovascular Devices - cardiovascular and respiratory.
6. Division of Ophthalmic and Ear, Nose and Throat Devices - ophthalmic devices and ear, nose, and throat.
7. Division of Reproductive, Abdominal, & Radiological Devices; radiology; obstetrics/gynecology; and gastroenterology/urology medical devices.
8. Division of Anesthesiology, General Hospital, Infection Control and Dental Devices - dental, infection control and general hospital devices.

246 - OFFICE OF SURVEILLANCE AND BIOMETRICS (HFZ-500) SUSAN N. GARDNER, Ph.D., DIRECTOR

The Office of Surveillance and Biometrics (OSB) manages Center programs to collect, evaluate and disseminate medical device data, including information on injuries and other device related experiences. OSB also provides statistical, epidemiological, and biometrics services in support of the operating and administrative programs of the Center.

This office has a staff and three Divisions as follows:

1. Issues Management Staff - Directs and monitors the analysis, resolution and development and solution implementation of postmarket issues.
2. Division of Surveillance Systems - Serves as the office focal point in planning, developing, implementing, and maintaining databases and information systems.
3. Division of Postmarket Surveillance - Plans, evaluates, and coordinates all postmarket surveillance activities.
4. Division of Biostatistics - Provides statistical computational support activities for internal and external Center programs.

247 - OFFICE OF IN VITRO DIAGNOSTICS (HFZ-440) STEVE GUTMAN, M.D., DIRECTOR