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 of Policy
For specific phone numbers and email addresses for each office, see the CDRH Management Directory by Organization.