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U.S. Department of Health and Human Services

Medical Devices

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How You Can Know If FDA Regulates an Over-The-Counter Test

To find out if an Over-The-Counter use test is regulated by FDA, you can look for it in IVD Over-The-Counter Database. To search the IVD Over-The-Counter Database:

  • Enter any word in the name of the test in the first space on the page where it says “Test Name."
  • You might also want to select the “Test Type” from the drop down menu if you know what kind of test it is.
  • You do not need to enter any other information.
  • Select Search at the bottom of the screen to submit your request.

The database will search for records that match your request. It will list the records, and you can select any that interest you. If the database finds no record of the test you requested, the test may not be regulated by FDA.

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Search In Vitro Test Database

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Contact FDA

301-796-5450
CDRH-Office of In Vitro Diagnostics and Radiological Health

Center for Devices and Radiological Health

10903 New Hampshire Avenue

WO66-5521

Silver Spring, MD 20993