Office of Compliance--What We Do
- Advise the Director of the Center for Devices and Radiological Health (CDRH) and other Agency officials on legal, administrative, and regulatory programs and policies concerning Agency compliance responsibilities relating to medical device and radiological health activities.
- Develop, direct, coordinate, evaluate, and monitor compliance and surveillance programs covering regulated industry.
- Conduct field tests and inspections when necessary for regulatory purposes, and evaluate industry quality control and testing programs to assure compliance with regulations.
- Provide advice to Agency field offices on, and manage CDRH activities relating to legal actions, case development, and contested case assistance.
- Manage and coordinate the administrative and regulatory responsibilities of the Agency's Bioresearch Monitoring Program for medical devices.
- Coordinate all field planning activities and issues all field assignments for CDRH.
- Provide technical support and guidance in the development and review of standards and regulations, and the training of Federal and State compliance personnel.
- Advise actual or potential manufacturers concerning the requirements of the law and regulations.
- Enforce 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.
- Develop 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 CDRH liaison with other Center and Agency components, industry, and trade associations for issues related to promotion, advertising, and labeling policy.
- Review and monitor trade and professional meetings, promotional materials, and professional journals to determine compliance with applicable regulations and determine off-label promotions.
- Develop, implement, and manage the CDRH's health fraud program. Coordinate activities with National Association of Attorney Generals, and Regional and District health fraud representatives.
- Develop field assignments for follow-up issues related to promotion and advertising and health fraud.