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FDA Forms
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| Form | Date | Food and Drug Administration Forms | Format | Contact Info |
|---|---|---|---|---|
| 2579 | 04/2011 | Report of Assembly of a Diagnostic X-Ray System (HTML) | (HTM - 0KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2579 | 12/2011 | Report of Assembly of a Diagnostic X-Ray System (Paper) | (PDF - 18KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 2767 | 01/2011 | Notice of Availability of Sample Electronic Product | (PDF - 364KB) |
DMQRP 301-796-5790 |
| 2877 | 01/2011 | Declaration for Imported Electronic Products Subject to Radiation Control Standards | (PDF - 399KB) |
DMQRP 301-796-5710 |
| 3147 | 04/2011 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3419 | 09/2010 | Medical Device Reporting Annual User Facility Report | (PDF - 418KB) |
OSB/CDRH/RSMB 301-796-6104 |
| 3422 | 01/2011 | Government Entity Declaration | (PDF - 439KB) |
Denise Robinson 301-796-5919 |
| 3427 | 06/2012 | Supplemental Data Sheet | (PDF - 420KB) |
Marjorie Shulman 301-796-6572 |
| 3429 | 07/2012 | General Device Classification Questionnaire | (PDF - 442KB) |
Marjorie Shulman 301-796-6572 |
| 3454 | 04/2013 | Certification: Financial Interest and Arrangements of Clinical Investigator | (PDF - 673KB) |
Colleen LoCicero 301-796-1114 |
| 3455 | 04/2013 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | (PDF - 674KB) |
Colleen LoCicero 301-796-1114 |
| 3500A | 06/2010 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions) | (HTM - 0KB) |
MedWatch 1-800-332-1088 |
| 3500B | 04/2013 | MEDWATCH Consumer Voluntary Reporting | (PDF - 1.2MB) |
MEDWATCH Saftey Alerts 1-800-FDA-1088 |
| 3514 | 01/2013 | CDRH Premarket Review Submission Cover Sheet | (PDF - 1.7MB) |
Ashley Boam 301-796-6341 |
| 3541 | 12/2010 | Premarket Notification [510(K)] Status Request and Response | (PDF - 419KB) |
William Sutton 301-796-5849 |
| 3601 | 01/2007 | Medical Device User Fee Cover Sheet | (HTM - 0KB) |
User Fees Financial Support Team 301-796-7200 |
| 3602 | 03/2013 | FY 2013 MDUFMA Small Business Qualification Certification For a Business Headquarter in the United States | (PDF - 1005KB) |
DSMICA 301-796-7100 800-638-2041 |
| 3602a | 03/2013 | FY 2013 MDUFMA Small Business Qualification Certification For a Business Headquarter Outside the United States | (PDF - 1MB) |
DSMICA 301-796-7100 800-638-2041 |
| 3608 | 06/2005 | Medical Device Fellowship Program Student Application | (HTM - 0KB) |
DMQRP 301-796-5696 |
| 3613 | 03/2012 | Supplementary Information Certificate to Foreign Government Requests | (PDF - 506KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9227. |
| 3613a | 03/2012 | Supplementary Information Certificate of Exportability Requests | (PDF - 527KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9227. |
| 3613b | 03/2012 | Supplementary Information Certificate of a Pharmaceutical Product | (PDF - 585KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 or CVM 240-276-9227. |
| 3613c | 03/2012 | Supplementary Information Non-Clinical Research Use Only Certificate | (PDF - 467KB) |
Import/Export Team CBER 301-827-6201 or CDRH 301-796-7400 |
| 3626 | 04/2011 | A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and their Major Components (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3627 | 04/2011 | Diagnostic X-Ray CT Products Radiation Safety Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3628 | 04/2011 | General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3628 | 07/2007 | General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF) | (PDF - 446KB) |
DMQRP 301-796-5710 |
| 3630 | 04/2011 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3631 | 11/2010 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products | (PDF - 548KB) |
DMQRP 301-796-5710 |
| 3631 | 04/2011 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3632 | 04/2011 | Guide for Preparing Product Reports on Lasers and Products Containing Lasers (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3636 | 04/2011 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3638 | 04/2011 | Guide for Filling Annual Reports for X-Ray Components and Systems (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3639 | 04/2011 | Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3640 | 01/2012 | Reporting Guide for Laser Light Shows and Displays | (PDF - 643KB) |
DMQRP 301-796-5790 |
| 3640 | 04/2011 | Reporting Guide for Laser Light Shows and Displays (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3641 | 04/2011 | Cabinet X-Ray Annual Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3642 | 04/2011 | General Correspondence Report for CDRH Electronic Submissions | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3643 | 04/2011 | Microwave Oven Products Annual Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3644 | 04/2011 | Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3645 | 04/2011 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3646 | 04/2011 | Mercury Vapor Lamp Products Radiation Safety Report (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3647 | 04/2011 | Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3649 | 02/2012 | Accidental Radiation Occurrence Report (PDF) | (PDF - 538KB) |
DMQRP 301-796-5710 |
| 3649 | 04/2011 | Accidental Radiation Occurrence Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3654 | 06/2011 | Standards Data Report for 510(K)s | (PDF - 438KB) |
Scott A. Colburn 301-796-6287 |
| 3660 | 04/2011 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3661 | 04/2011 | A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic (HTML) | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3662 | 04/2011 | A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devise Intended for Diagnostic Use (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3663 | 04/2011 | Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (HTML) | (HTM - 0KB) |
DMQRP 301-796-5790 |
| 3670 | 03/2008 | MedSun (Medical Product Surveillance Network) | (HTM - 0KB) |
Marilyn Flack 301-796-6118 |
| 3752 | 06/2010 | Pre-Amendment Device Determination Request | (PDF - 402KB) |
Bryan Benesch 301.796.5506 |
| 3759 | 04/2011 | Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (HTML) | (HTM - 0KB) |
Cory Tylka 301-796-5869 |
| 3759 | 11/2010 | Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products | (PDF - 487KB) |
Cory Tylka 301-796-5869 |
| 3760 | 11/2010 | Guide for Preparing Product Reports for Medical Ultrasound Products | (PDF - 497KB) |
Cory Tylka 301-796-5869 |
| 3801 | 03/2010 | Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps | (PDF - 716KB) |
Cory Tylka 301-796-5869 |
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