Center for Devices and Radiological Health, U.S. Food and Drug Administration

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
horizonal rule

Medical Device User Fee and Modernization Act (MDUFMA) of 2002

CDRH Contacts for Specific Billing Issues

Issue	Contact(s)
General questions and appeals objecting to paying a user fee for a 510(k)	Questions: James G. Norman 301-827-6829 Appeals: Bob Navazio, OCD 301-827-7996
All other questions and appeals concerning 510(k)s (including bundling, withdrawals, 510(k) exemptions)	Questions: CDRH 510(k) Staff 301-594-1190 Appeals: Director, 510(k) Staff 301-594-1190
General questions and appeals objecting to paying a user fee for a premarket application (PMA, PDP, or PMR) or supplement	Questions: James G. Norman 301-827-6829 Appeals: Bob Navazio, OCD 301-827-7996
All other questions and appeals concerning premarket applications and supplements (including bundling and issues on the type of PMA submission)	Questions: CDRH PMA Staff 301-594-2186 Appeals: Director, PMA Staff 301-594-2186
Questions and appeals concerning qualification for small business fees and waivers (including "first premarket application" fee waiver)	Questions: Regulatory Assistance Branch DSMICA 301-443-6597, ext. 115 Appeals: Director, Division of Small Manufacturers, International and Consumer Assistance
Government entity questions and appeals	Questions: Regulatory Assistance Branch 301-443-6597, ext. 115 Appeals: Director, Division of Small Manufacturers, International and Consumer Assistance
Questions concerning how to pay an invoice or submit payment for a new application (e.g. What’s a billing number?; What’s FDA's tax ID number?; How to send payment by courier / delivery service; How are payments made by wire transfer?)	Questions: Financial Management Branch 301-594-3006, ext. 161
Questions and appeals concerning qualification for a pediatric product fee exemption	Questions: CDRH 510(k) Staff 301-594-1190 -or- CDRH PMA Staff 301-594-2186 Appeals: Director, 510(k) Staff 301-594-1190 -or- Director, PMA Staff 301-594-2186