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FREEDOM OF INFORMATION

The Freedom of Information Act (FOIA) allows anyone to request FDA records. However, under FOIA, information that is deemed exempt from disclosure may not be released to the public. Examples of this type of information typically include: preclinical or clinical data from ongoing, completed, or discontinued studies; mechanical drawings; and specific chemical compositions. In addition, FDA cannot acknowledge the existence of an IDE study unless we know that the company has gone public with that information. Even then, in most cases, no details of that study can be given per FDA regulations. We are not denying any request; however, this clarification is provided so that you do not have unrealistic expectations on what information you can obtain through FOIA.

To access additional information on FOIA, to check to see if the information you want is already on FDA’s website, to find out about FDA public reading rooms, and to access the complete handbook for requesting information through FOIA, please go to our website at http://www.fda.gov/foi/foia2.htm. You may also obtain FOIA information by calling 1-888-INFO-FDA (1-888-463-6332). FDA may charge a fee for completing a FOIA request.

Updated June 8, 2004

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Center for Devices and Radiological Health / CDRH