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U.S. Department of Health and Human Services

FDA Freedom of Information Act (FOIA)

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The 1996 amendments to the Freedom of Information Act (FOIA) mandate publicly accessible "electronic reading rooms" with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.

Before submitting an FOIA request, please check to see if the information you are looking for is already available on FDA's Web site. You can use our search engine to help you find what you're looking for.

You may be charged a fee for processing your FOIA request. Information about fees is at: https://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm

Electronic FOIA Request

You may go to the FOIA request page and submit a request online. Please note that requests for information under the Privacy Act cannot be submitted online, and must be sent by mail to FDA’s Division of Freedom of Information. For contact information, please see FDA’s FOIA page.

If you submit your request(s) online, submission of an additional confirmation copy by mail or fax is unnecessary and may result in double processing and double billing.

Please note that processing time for requests for medical device approval records, including PMAs, 510Ks, and De Novo Classifications, is currently 18 to 24 months.

**Please read before submitting your online FOIA Request**

  • If you are seeking inspection records for a facility in the United States, please include the location (city and state) of the inspected facility. If you are seeking inspection records for a facility not in the United States, please indicate the product type at issue in the inspection (ie human drugs, vaccines, devices, animal drugs, etc) so that we can properly assign your request.
    • Please note that processing time for Forms 483 (Notice of Inspectional Observations) is generally faster than processing time for Establishment Inspection Reports, and therefore processing fees for 483s are lower as well.
  • If you are seeking medical device adverse event reports,please see: https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/ucm127891.htm.
  • If you are seeking human drug adverse event reports, please see: https://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/surveillance/adversedrugeffects/ucm070093.htm. Please note that any FOIA requests for adverse event reports must include the name(s) of the specific product(s).
  • If you are a third party seeking records about a patient, employee, or other named individual, please include a signed authorization from that individual with your request.
  • Limiting your request to records previously released under FOIA for a particular subject will significantly reduce processing time and fees (assuming records on that subject have ever been released).
  • Please read the requirement for a grant of expedited processing prior to checking the box for expedited processing:
  • If you are a media/nonprofit/educational institution/student/scientific institution requester, you will not incur processing fees for search or review time; therefore, a request for a fee waiver is likely unnecessary. In the unlikely event that you receive an invoice, you can seek a waiver of fees at that time.
Privacy Act Statement
The collection of this information is authorized by the Freedom of Information Act (FOIA, 5 U.S.C. § 552). The collected information is used by FOIA staff to respond to your requests, and by appeals officials and members of the Office of the General Counsel. Provision of the requested information is voluntary (as that word is used by the Privacy Act of 1976), but may be required in order to process and respond to your request. Failure to provide your personally identifying information may result in FDA’s inability to respond to your request. A full list of the agency’s routine uses (disclosures) of the PII you submit is available at [this link].