Who We Are
The Division of Information Disclosure (DID) within CDRH’s Office of Communication and Education (OCE) ensures transparency of Center and government operations by releasing information that is consistent with statutory, department, agency and center policy. We manage the Freedom of Information Act (FOIA) requests for FDA records related to CDRH and handle the Privacy Act and Records Management programs for the Center. Requestors may include the public, manufacturers, Federal, foreign, state or local government agencies, Congressional staffers, other offices within the Center, and the Office of the Chief Council. The Division reviews records to ensure that no commercial, financial, trade secret, or confidential pre-decisional information related to an open investigation or information that would result in an invasion of personal privacy is not released in accordance with the FOIA, regulations and policy.
What We Do
- Respond to requests for CDRH records
- Handle Privacy Impact Assessments, System of Record Notices, Privacy breaches, and privacy Paperwork Reduction Act and Information collection reviews
- Review Center documents and information to ensure transparency prior to posting to the public website. (i.e. Warning Letters, CLIA and De Novo summaries, etc.)
- Handle records management for the Center by drafting file plans, records schedules, and ensuring the Center employees gets trained on the Federal Records Act and records management policies
- Review and redact records that are the subject of litigation
To submit a FOIA request:
- Online: Go to FDA FOIA Online Request Form
- Mail or fax: Go to How to Make a FOIA Request
To check the status of a FOIA request for CDRH:
- Phone: 301-796-8118
- Email: CDRH-FOIStatus@fda.hhs.gov
For more information on the FOIA and how to get CDRH records, visit the CDRH FOIA webpage.
For specific phone numbers and email addresses for each office, division, and branch, see the CDRH Management Directory by Organization.
For general questions about medical devices regulation, contact the Division of Industry and Consumer Education at firstname.lastname@example.org or 800.638.2041 or 301.796.7100.