Office of Policy Also referred to as: OP
Ellen J. Flannery, J.D.
Deputy Center Director for Policy
Director, Office of Policy
Who We Are
The Office of Policy provides leadership for all policy-related activities at the Center for Devices and Radiological Health (CDRH).
What We Do
- Provide oversight and leadership in the development of regulations, guidances, policies, and procedures concerning medical device and radiation-emitting products under the Federal Food, Drug, and Cosmetic Act.
- Provide leadership in CDRH legislative activities, including the development and evaluation of legislation, responses to congressional inquiries, and briefings for congressional members and their staff.
- Coordinate the development, review and submission of Federal Register publications for CDRH and conduct Paperwork Reduction Act analysis.
- Provide leadership and expertise in the planning and implementation of proposals for new regulations and policy statements.
- Assist in resolution of disputes, grievances and appeals through the Ombudsman.
Office Organization
- Office of Policy
Contact Us
Phone: 301-796-5441
For specific phone numbers and email addresses for each office, see the CDRH Management Directory by Organization.
For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at [email protected] or 800.638.2041 or 301.796.7100.