|
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  |
|
 | ||
|
|
|||
|
||||
Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
If the preceding information was insufficient to help you ascertain the "Is-it-a-device?" status of your product, or whether your product is a "drug or device?", feel free to call Mr. Eugene M. Berk at 240-276-0104, Electronic Mail at emb@cdrh.fda.gov, or send a fax to 240-276-0101 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. Bryan Benesch , at 240-276-0141, Electronic Mail at bhb@cdrh.fda.gov, or send a fax to 240-276-0101.
Updated August 8, 2005
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH
