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U.S. Department of Health and Human Services

About FDA

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How to Get Information from CDRH

Background

The Freedom of Information Act (FOIA) requires federal agencies to disclose records requested in writing by any person. However, federal agencies may withhold information pursuant to nine exemptions and three exclusions which are contained in the statute. Each federal agency is responsible for meeting its FOIA responsibilities for its own records.

Information Available From the CDRH Website

CDRH makes a variety of information available through its Internet site. Before CDRH created this site, much of the information could only be obtained by submitting a FOIA request and paying certain fees. Before you submit a FOIA request, please check our website. If the information you need is available, you can save time and money.

Some types of information may be viewed by simply clicking on a link. Other information requires a search: you specify certain criteria to describe the information you need and retrieve either the information or a set of links leading to the information.

Type of InformationFormat
Releasable 510(k)sSearchable and ZIP
Releasable PMAsSearchable and ZIP
510(k) SummariesSearchable
Product Code DataSearchable and ZIP
Adverse Events Some Searchable and ZIP
Registration and Listing DataSearchable and ZIP
Certified Mammography FacilitiesSearchable
Blue Book MemorandaViewable Directly
Guidance DocumentsSearchable
NHRIC DataSearchable
FDA Recognized Consensus StandardsSearchable
CLIASome Viewable Directly
X-Ray AssemblerSearchable and ZIP

 

Information Available From Other FDA Resources

Certain materials about CDRH-related matters for public distribution (e.g., press releases, consumer publications, speeches, congressional testimony) are available from the FDA Internet site. Some materials are also available locally from the more than 40 FDA public affairs specialists throughout the United States.

FDA also maintains accessible "electronic reading rooms" with agency FOIA response materials and other information routinely available to the public, with electronic search and indexing features.

Submitting an FOI Request

If the information you seek is not available from any of the above sources, you must submit a written Freedom of Information Act (FOIA) request to FDA or submit a FOIA request online. CDRH is not able to accept FOIA requests via email.