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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 |
|---|---|---|---|---|
| 2579 | 06/2008 | Report of Assembly of a Diagnostic X-Ray System | (DOC - 28KB) |
At the warehouse Elizabeth.Sands@fda.hhs.gov |
| 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 |
| 3147 | 05/2007 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device | (PDF - 486KB) |
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 |
| 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 |
| 3626 | 07/2007 | A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components | (PDF - 3852KB) |
DMQRP 301-796-5710 |
| 3627 | 07/2007 | Diagnostic X-Ray CT Products Radiation Safety Report | (PDF - 477KB) |
DMQRP 301-796-5710 |
| 3629 | 07/2007 | Abbreviated Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3630 | 07/2007 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products | (PDF - 1251KB) |
DMQRP 301-796-5710 |
| 3631 | 07/2007 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products | (PDF - 670KB) |
DMQRP 301-796-5710 |
| 3632 | 07/2007 | Guide for Preparing Product Reports on Lasers and Products Containing Lasers | (PDF - 507KB) |
DMQRP 301-796-5710 |
| 3633 | 07/2007 | General Variance Request | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3634 | 07/2007 | Television Products Annual Report | (PDF - 2499KB) |
DMQRP 301-796-5710 |
| 3635 | 07/2007 | Laser Light Show Notification | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3636 | 07/2007 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show | (PDF - 399KB) |
DMQRP 301-796-5710 |
| 3637 | 07/2007 | Laser Original Equipment Manufacture Report | (HTM - 0KB) |
DMQRP 301-796-5710 |
| 3638 | 07/2007 | Guide for Filling Annual Reports for X-Ray Components and Systems | (PDF - 440KB) |
DMQRP 301-796-5710 |
| 3639 | 07/2007 | Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | (PDF - 1031KB) |
DMQRP 301-796-5710 |
| 3640 | 07/2007 | Reporting Guide for Laser Light Shows and Displays | (PDF - 1003KB) |
DMQRP 301-796-5710 |
| 3641 | 07/2007 | Cabinet X-Ray Annual Report | (PDF - 437KB) |
DMQRP 301-796-5710 |
| 3643 | 07/2007 | Microwave Oven Products Annual Report | (PDF - 2578KB) |
DMQRP 301-796-5710 |
| 3644 | 07/2007 | Guide for Preparing Product Reports for Ultrasonic Therapy Products | (PDF - 805KB) |
DMQRP 301-796-5710 |
| 3645 | 07/2007 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products | (PDF - 516KB) |
DMQRP 301-796-5710 |
| 3646 | 07/2007 | Mercury Vapor Lamp Products Radiation Safety Report | (PDF - 1020KB) |
DMQRP 301-796-5710 |
| 3647 | 07/2007 | Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps | (PDF - 654KB) |
DMQRP 301-796-5710 |
| 3654 | 09/2007 | Standards Data Report for 510(K)s | (PDF - 515KB) |
Bob Gatling 301-796-6560 |
| 3659 | 07/2007 | Reporting and Compliance Guide for Television Products | (PDF - 2501KB) |
DMQRP 301-796-5710 |
| 3660 | 07/2007 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens | (PDF - 2579KB) |
DMQRP 301-796-5710 |
| 3661 | 07/2007 | A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use | (PDF - 691KB) |
DMQRP 301-796-5710 |
| 3662 | 07/2007 | A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use | (PDF - 372KB) |
DMQRP 301-796-5710 |
| 3663 | 07/2007 | Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) | (PDF - 440KB) |
DMQRP 301-796-5710 |
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