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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Step One:
Access: CDRH
Classification Database.
This database contains the names of items we consider devices and the associated codes developed by the FDA to support its regulatory and administrative processes. If you find a name that describes your product, in all but a few instances, it will be considered a device regulated by the FDA.
Note: Enter only one word (search term) of the device
name in the search criteria. Your search results will include the Generic Device
Name, Regulation Number, Medical Specialty, Product Code, Device Class, and
Tier for each item that matches your search term. The following example is one
of four matches for the search term condom.
Copy the information from the search results into your notepad, print out the search results or write down the above information for use in the following steps.
Then click the back button in your web browser twice to return to this page and continue with Step Two.
Step Two:
If the classification database results are inconclusive, check the Precedent
Correspondence (Previous decisions on products) for information on a related
product that may assist you in determining the requirements you need to consider
for your product.
Step Three:
Access: Contacts For Device / Not A Device Decision
If neither of the above is sufficient to help you ascertain the status of your product
feel free to call Mr. Eugene M. Berk at (301) 594-1190 or send a fax to (301) 594-2977 for
assistance. If your question pertains more to legal or compliance Is-it-a-device status
issues, such as may the item be legally exported outside of the U.S., may it be legally
imported into the U.S., or your legal responsibilities with respect to the need to comply
with the registration, listing, premarket notification, medical device reporting
regulations, you should call Mr. Wally Pellerite, at (301) 594-4692 or send a fax to (301)
594-4610.
Information Sources to help in determining if you have a medical device
Classification
Database
Precedent Correspondence
Contacts For Device / Not A Device Decision
Updated 5/28/1999
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Center for Devices and Radiological Health / CDRH
