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.
Contact FDA
301-796-5450
CDRH-Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-5521
Silver Spring, MD 20993
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