• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

Device -- Not a Device

Step One:

Access: CDRH Classification Database.

The classification database contains products 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 is a device regulated by the FDA.

Search the product classification database at CDRH Classification Database. If you use the advance search form, we recommend that you enter only one word or search term for "device" in the search criteria. You may narrow your search by completing other search criteria; however, this may also limit your results.

The following is an example of the partial results you will receive from your search.

Product Classification Database

DeviceCondom
Regulation DescriptionCondom.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelObstetrics/Gynecology
Product CodeHIS
Submission Type510(k)
Regulation Number884.5300
Device Class2
GMP Exempt?No

Copy or print this information from the search results for future reference.

Then click the back button in your web browser twice to return to this page and continue with Step Two.

Step Two:

Access: Contacts For Device / Not A Device Decision

If the preceding information does not result in your determining whether your product is a device as defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA), you may contact the Center’s Device Determination Officers, Office of Compliance, by e-mail at DeviceDetermination@fda.hhs.gov. They only determine whether or not a product is a device. They do not determine what the classification of the device is nor whether a pre-market application is required. Classification and application decisions are made by the Office of Device Evaluation (ODE). The Division of Small Manufacturers, International and Consumer Assistance can assist you with identifying the correct ODE Division to contact for assistance.
 

Information Sources to help in determining if you have a medical device

Classification Database
Contacts For Device / Not A Device Decision