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| FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
|---|---|---|---|---|
| 2579 | 06/08 | Report of Assembly of a Diagnostic X-Ray System | |
PPF |
| 2767 | 05/07 | Notice of Availability of Sample Electronic Product | |
DMQRP 240-276-3332 |
| 2783 | 10/80 | Mobile Radiographic Systems Field Test Record | |
PPF |
| 2784 | 10/80 | Above Table X-Ray Source Radiographic Systems | |
PPF |
| 2785 | 05/82 | Dental Radiographic Systems Field Test Record {2784.1-Pg1, 2784.2-Pg2, 2784.3-Pg3} | |
PPF |
| 2786 | 05/82 | Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record | |
Stephen Toigo 301-827-2906 |
| 2877 | 12/03 | Declaration for Imported Electronic Products Subject to Radiation Control Standards | |
DMQRP 240-276-3332 |
| 3147 | 05/07 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device | |
DMQRP 240-276-3332 |
| 3419 | 10/07 | Medical Device Reporting Annual User Facility Report {Instructions} | |
OSB/CDRH/RSMB 240-276-3464 |
| 3422 | 08/07 | Government Entity Declaration | |
Denise Robinson 240-276-3278 |
| 3427 | 01/03 | Supplemental Data Sheet | |
Marjorie Shulman 240-276-4040 |
| 3429 | 01/03 | General Device Classification Questionnaire | |
Marjorie Shulman 240-276-4040 |
| 3454 | 04/06 | Certification: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3455 | 04/06 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-796-1282 |
| 3500 | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3500A | 02/06 | MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3514 | 03/08 | CDRH Premarket Review Submission Cover Sheet | |
Bob Gatling 240-276-4015 |
| 3541 | 09/07 | Premarket Notification [510(K)] Status Request and Response | | John Stigi 240-276-3150 EX 124 |
| 3571 | 06/06 | Infusion Pump Information Submission Report {Instructions} | |
Morgan Warner 240-276-3461 |
| 3601 | 01/07 | Medical Device User Fee Cover Sheet | |
User Fees Financial Support Team 301-827-9539 |
| 3602 | 10/08 | FY MDUFMA Small Business Qualification Certification For a Business Headquarter in the United States | |
James G. Norman 240-276-3806 |
| 3602a | 10/08 | FY MDUFMA Small Business Qualification Certification For a Business Headquarter Outside the United States | |
James G. Norman 240-276-3806 |
| 3608 | 06/05 | Medical Device Fellowship Program Student Application {Instructions} | |
Medical Device Fellowship Program 240-276-3816 |
| 3613 | 06/06 | Supplementary Information Certificate to Foreign Government Requests | |
Import/Export Team CDRH 240 276-0132 |
| 3613a | 09/06 | Supplementary Information Certificate of Exportability Requests | |
Import/Export Team CDRH 240 276-0132 |
| 3613c | 06/06 | Supplementary Information Non-Clinical Research Use Only Certificate | |
Import/Export Team CDRH 240 276-0132 |
| 3626 | 07/07 | A Guide for the Submission of Initial Reports on Diagnostic X-ray Systems and Their Major Components | |
DMQRP 240-276-3332 |
| 3627 | 07/07 | Diagnostic X-Ray CT Products Radiation Safety Report | |
DMQRP 240-276-3332 |
| 3630 | 07/07 | Guide for Preparing Product Reports on Sunlamps and Sunlamp Products | |
DMQRP 240-276-3332 |
| 3631 | 07/07 | Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products | |
DMQRP 240-276-3332 |
| 3632 | 07/07 | Guide for Preparing Product Reports on Lasers and Products Containing Lasers | |
DMQRP 240-276-3332 |
| 3634 | 07/07 | Television Products Annual Report | |
DMQRP 240-276-3332 |
| 3636 | 07/07 | Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show | |
DMQRP 240-276-3332 |
| 3638 | 07/07 | Guide for Filling Annual Reports for X-Ray Components and Systems | |
DMQRP 240-276-3332 |
| 3639 | 07/07 | Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 | |
DMQRP 240-276-3332 |
| 3640 | 07/07 | Reporting Guide for Laser Light Shows and Displays | |
DMQRP 240-276-3332 |
| 3641 | 07/07 | Cabinet X-Ray Annual Report | |
DMQRP 240-276-3332 |
| 3643 | 07/07 | Microwave Oven Products Annual Report | |
DMQRP 240-276-3332 |
| 3644 | 07/07 | Guide for Preparing Product Reports for Ultrasonic Therapy Products | |
DMQRP 240-276-3332 |
| 3645 | 07/07 | Guide for Preparing Annual Reports for Ultrasonic Therapy Products | |
DMQRP 240-276-3332 |
| 3646 | 07/07 | Mercury Vapor Lamp Products Radiation Safety Report | |
DMQRP 240-276-3332 |
| 3647 | 07/07 | Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps | |
DMQRP 240-276-3332 |
| 3654 | 09/07 | Standards Data Report for 510(K)s | |
Bob Gatling 240-276-4015 |
| 3659 | 07/07 | Reporting and Compliance Guide for Television Products | |
DMQRP 240-276-3332 |
| 3660 | 07/07 | Guidance for Preparing Reports on Radiation Safety of Microwave Ovens | |
DMQRP 240-276-3332 |
| 3661 | 07/07 | A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use | |
DMQRP 240-276-3332 |
| 3662 | 07/07 | A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use | |
DMQRP 240-276-3332 |
| 3663 | 07/07 | Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) | |
DMQRP 240-276-3332 |
| 3670 | 03/08 | MedSun (Medical Product Surveillance Network) |
|
Marilyn Flack 240-276-2391 |
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Edition: November 25, 2008