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About FDA
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FDA Forms
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| Form | Date | Food and Drugs Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 2767 | 05/2007 | Notice of Availability of Sample Electronic Product | (PDF - 470KB) |
DMQRP 301-796-5710 |
| 2877 | 02/2008 | Declaration for Imported Electronic Products Subject to Radiation Control Standards | (PDF - 369KB) |
DMQRP 301-796-5710 |
| 3419 | 10/2007 | Medical Device Reporting Annual User Facility Report | (PDF - 518KB) |
OSB/CDRH/RSMB 301-796-6104 |
| 3422 | 08/2007 | Government Entity Declaration | (PDF - 405KB) |
Denise Robinson 301-796-5919 |
| 3427 | 01/2009 | Supplemental Data Sheet | (PDF - 625KB) |
Marjorie Shulman 301-796-6572 |
| 3429 | 01/2009 | General Device Classification Questionnaire | (PDF - 656KB) |
Marjorie Shulman 301-796-6572 |
| 3514 | 03/2008 | CDRH Premarket Review Submission Cover Sheet | (PDF - 1434KB) |
Bob Gatling 301-796-6560 |
| 3541 | 09/2007 | Premarket Notification [510(K)] Status Request and Response | (PDF - 54KB) |
John Stigi 301-796-5848 |
| 3571 | 06/2006 | Infusion Pump Information Submission Report | (PDF - 186KB) |
Mary Brady 301-796-6089 |
| 3601 | 01/2007 | Medical Device User Fee Cover Sheet | (HTM - 0KB) |
User Fees Financial Support Team 301-796-7200 |
| 3602 | 08/2009 | FY 2010 MDUFMA Small Business Qualification Certification For a Business Headquarter in the United States | (PDF - 500KB) |
Yung Pak 301-796-5856 |
| 3602a | 08/2009 | FY 2010 MDUFMA Small Business Qualification Certification For a Business Headquarter Outside the United States | (PDF - 500KB) |
Yung Pak 301-796-5856 |
| 3608 | 06/2005 | Medical Device Fellowship Program Student Application | (HTM - 0KB) |
DMQRP 301-796-5696 |
| 3613 | 06/2006 | Supplementary Information Certificate to Foreign Government Requests | (PDF - 201KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613a | 09/2006 | Supplementary Information Certificate of Exportability Requests | (PDF - 403KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613b | 06/2006 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 328KB) |
Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3613c | 06/2006 | Supplementary Information Non-Clinical Research Use Only Certificate | (PDF - 311KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-0132 |
| 3628 | 07/2007 | General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3642 | 07/2007 | General Correspondence Report for CDRH Electronic Submissions | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3649 | 07/2007 | Accidental Radiation Occurrence Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3654 | 09/2007 | Standards Data Report for 510(K)s | (PDF - 515KB) |
Bob Gatling 301-796-6560 |
| 3670 | 03/2008 | MedSun (Medical Product Surveillance Network) | (HTM - 0KB) |
Marilyn Flack 301-796-6118 |
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