What We Do
- Office of Compliance |
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- Advises the Center Director and other Agency officials on legal, administrative, and regulatory programs and policies concerning Agency compliance responsibilities relating to medical device and radiological health activities.
- Develops, directs, coordinates, evaluates, and monitors compliance and surveillance programs covering regulated industry.
- Conducts field tests and inspections when necessary for regulatory purposes and evaluates industry quality control and testing programs to assure compliance with regulations.
- Provides advice to Agency field offices on, and manages Center activities relating to legal actions, case development, and contested case assistance.
- Manages and coordinates the administrative and regulatory responsibilities
of the Agency's Bioresearch Monitoring Program for
medical devices.
- Coordinates all field planning activities and issues all field assignments for the Center.
- Provides technical support and guidance in the development and review of standards and regulations, and the training of Federal and State compliance personnel.
- Advises actual or potential manufacturers concerning the requirements of the law and regulations.
- Enforces the Medical Device Amendments of 1976 including the Safe Medical Devices Acts of 1990 and 1992 and the Radiation Control for Health and Safety Act of 1972 as they relate to promotion and advertising.
- Develops regulations and Compliance Policy Guides including those related to restricted devices, restricted device labeling, health fraud, and the promotion of devices pending pre-market clearance.
- Serves as the Center's liaison with other Center and Agency components, industry, and trade associations for issues related to promotion, advertising, and labeling policy.
- Reviews and monitors trade and professional meetings, promotional materials, and professional journals to determine compliance with applicable regulations and determine off-label promotions.
- Develops, implements, and manages the Center's health fraud program. Coordinates activities with National Association of Attorney Generals, and Regional and District health fraud representatives.
- Develops field assignments for follow-up issues related to promotion and advertising and health fraud.
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Center for Devices and Radiological Health / CDRH