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Form Date Description Format Contact Info
2579  04/2014 Report of Assembly of a Diagnostic X-Ray System (Paper)  (HTM - 0KB) At the warehouse
formsmanager@OC.FDA.GOV
2579  04/2011 Report of Assembly of a Diagnostic X-Ray System (HTML)  (HTM - 0KB) James Graves at 301-796-4443
2579  06/2011 Report of Assembly of a Diagnostic X-Ray System (FAQ & Instructions)  (HTM - 0KB) Division of Radiological Health
301-796-5790
2767  05/2014 Notice of Availability of Sample Electronic Product (PDF)  (PDF - 627KB) DRH
301-796-5790
2782  09/1998 Field Test Record Continuation Sheet (PDF)  (PDF - 1MB) Nick Walker
301-796-5910
2783  10/1980 Mobile Radiographic Systems Field Test Record (PDF)  (PDF - 19KB) Nick Walker
301-796-5910
2784  10/1980 Above Table X-Ray Source Radiographic Systems (PDF)  (PDF - 30KB) Nick Walker
301-796-5910
2785  05/1982 Dental Radiographic Systems Field Test Record (PDF)  (PDF - 21KB) Nick Walker
301-796-5910
2877  08/2014 Declaration for Imported Electronic Products Subject to Radiation Control Standards (PDF)  (PDF - 670KB) DRH
301-796-5790
3068  08/1992 Peak Kilovoltage Determination Field Test Record (PDF)  (PDF - 57KB) Nick Walker
301-796-5910
3069  10/1980 Above Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record (PDF)  (PDF - 19KB) Nick Walker
301-796-5910
3071  04/2001 General Information Field Test Record (PDF)  (PDF - 20KB) Nick Walker
301-796-5910
3147  04/2011 Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device (HTML)  (HTM - 0KB) DRH
301-796-5790
3297  04/1984 Head and Neck Radiographic Systems Field Test Record (PDF)  (PDF - 29KB) Nick Walker
301-796-5910
3419  03/2016 Medical Device Reporting Annual User Facility Report (PDF)  (PDF - 699KB) OSB/CDRH/RSMB
301-796-6104
3422  08/2013 Government Entity Declaration (PDF)  (PDF - 727KB) Denise Robinson
301-796-5919
3427  10/2015 Supplemental Data Sheet (PDF)  (PDF - 692KB) Marjorie Shulman
301-796-6572
3429  10/2015 General Device Classification Questionnaire (PDF)  (PDF - 718KB) Marjorie Shulman
301-796-6572
3454  03/2016 Certification: Financial Interest and Arrangements of Clinical Investigator (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3455  03/2016 Disclosure: Financial Interest and Arrangements of Clinical Investigators (PDF)  (PDF - 673KB) Colleen LoCicero
301-796-1114
3500  10/2015 MedWatch: The FDA Safety Information and Adverse Reporting Program (PDF)  (PDF - 3.5MB) MEDWATCH
1-800-FDA-1088
3500A  10/2015 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (PDF)  (PDF - 2.7MB) MEDWATCH
1-800-FDA-1088
3500A  02/2013 MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory (Instructions)  (PDF - 217KB) MedWatch
1-800-332-1088
3500B  10/2015 MEDWATCH Consumer Voluntary Reporting (PDF)  (PDF - 1.2MB) MEDWATCH Saftey Alerts
1-800-FDA-1088
3514  01/2013 CDRH Premarket Review Submission Cover Sheet (PDF)  (PDF - 1.7MB) Edwena R. Jones
301-796-6308
3601  08/2012 Medical Device User Fee Cover Sheet (HTML)  (HTM - 0KB) User Fees Financial Support Team
301-796-7200
3601a  08/2012 FURLS User Fee (HTM)  (HTM - 0KB) User Fees Financial Support Team
301-796-7200
3602  09/2015 FY 2016 MDUFA Small Business Qualification and Certification For a Business Headquartered in the United States (PDF)  (PDF - 1010KB) DICE
800-638-2041
3602a  09/2015 FY 2016 MDUFA Foreign Small Business Qualification and Certification For a Business Headquartered Outside the United States (PDF)  (PDF - 1MB) DICE
800-638-2041
3608  06/2005 Medical Device Fellowship Program Student Application (HTML)  (HTM - 0KB) DMQRP
301-796-5696
3613  08/2015 Supplementary Information Certificate to Foreign Government Requests (PDF)  (PDF - 838KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613a  08/2015 Supplementary Information Certificate of Exportability Requests (PDF)  (PDF - 840KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613b  04/2015 Supplementary Information Certificate of a Pharmaceutical Product (PDF)  (PDF - 794KB) Import/Export Team
CBER 301-827-6201 or
CDRH 301-796-7400 or
CVM 240-402-5508
3613c  08/2015 Supplementary Information Non-Clinical Research Use Only Certificate (PDF)  (PDF - 759KB) 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) DRH
301-796-5790
3627  04/2011 Diagnostic X-Ray CT Products Radiation Safety Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3628  02/2016 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (PDF)  (PDF - 801KB) DRH
301-796-5790
3628  04/2011 General Annual Report (Includes Medical, Analytical, and Industrial X-Ray Products Annual Report) (HTML)  (HTM - 0KB) DRH
301-796-5790
3630  04/2011 Guide for Preparing Product Reports on Sunlamps and Sunlamp Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3631  02/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (PDF)  (PDF - 823KB) DRH
301-796-5790
3631  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Sunlamps and Sunlamp Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3632  04/2011 Guide for Preparing Product Reports on Lasers and Products Containing Lasers (HTML)  (HTM - 0KB) DRH
301-796-5790
3636  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (HTML)  (HTM - 0KB) DRH
301-796-5790
3636  03/2014 Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show (PDF)  (PDF - 811KB) DRH
301-796-5790
3638  03/2014 Guide for Filling Annual Reports for X-Ray Components and Systems (PDF)  (PDF - 871KB) DRH
301-796-5790
3638  04/2011 Guide for Filling Annual Reports for X-Ray Components and Systems (HTML)  (HTM - 0KB) DRH
301-796-5790
3639  03/2014 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (PDF)  (PDF - 988KB) DRH
301-796-5790
3639  04/2011 Guidance for Submission of Cabinet X-Ray System Reports Pursuant to 21 CFR 1020.40 (HTML)  (HTM - 0KB) DRH
301-796-5790
3640  03/2014 Reporting Guide for Laser Light Shows and Displays (PDF)  (PDF - 919KB) DRH
301-796-5790
3640  04/2011 Reporting Guide for Laser Light Shows and Displays (HTML)  (HTM - 0KB) DRH
301-796-5790
3641  04/2011 Cabinet X-Ray Annual Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3642  04/2011 General Correspondence Report for CDRH Electronic Submissions (HTML)  (HTM - 0KB) DRH
301-796-5790
3643  03/2014 Microwave Oven Products Annual Report (PDF)  (PDF - 865KB) DRH
301-796-5790
3643  04/2011 Microwave Oven Products Annual Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3644  04/2011 Guide for Preparing Product Reports for Ultrasonic Therapy Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3645  04/2011 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3645  06/2015 Guide for Preparing Annual Reports for Ultrasonic Therapy Products (PDF)  (PDF - 761KB) DRH
301-796-5790
3646  04/2011 Mercury Vapor Lamp Products Radiation Safety Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3647  04/2011 Guide for Preparing Annual Reports on Radiation Safety Testing of Mercury Vapor Lamps (HTML)  (HTM - 0KB) DRH
301-796-5790
3649  04/2011 Accidental Radiation Occurrence Report (HTML)  (HTM - 0KB) DRH
301-796-5790
3649  06/2014 Accidental Radiation Occurrence Report (PDF)  (PDF - 766KB) DRH
301-796-5790
3654  04/2014 Standards Data Report for 510(K)s (PDF)  (PDF - 2.4MB) Scott A. Colburn
301-796-6287
3660  04/2011 Guidance for Preparing Reports on Radiation Safety of Microwave Ovens (HTML)  (HTM - 0KB) DRH
301-796-5790
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) DRH
301-796-5790
3661  06/2015 A Guide for the Submission of an Abbreviated Report on X-ray Tables, Cradles, Film Changers or Cassette Holders Intended for Diagnostic Use (PDF)  (PDF - 694KB) DRH
301-796-5790
3662  12/2015 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devices Intended for Diagnostic Use (PDF)  (PDF - 729KB) DRH
301-796-5790
3662  04/2011 A Guide for Submission of an Abbreviated Radiation Safety Reports on Cephalometric Devise Intended for Diagnostic Use (HTML)  (HTM - 0KB) DRH
301-796-5790
3663  03/2016 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (PDF)  (PDF - 742KB) DRH
301-796-5790
3663  04/2011 Abbreviated Reports on Radiation Safety for Microwave Products (Other than Microwave Ovens) (HTML)  (HTM - 0KB) DRH
301-796-5790
3670  11/2014 MedSun (Medical Product Surveillance Network) (HTML)  (HTM - 0KB) Jill Marion
301- 796-6128
3671  01/2015 Common EMEA/FDA Application for Orphan Medicinal Product Designation (PDF)  (PDF - 850KB) Kathy Needleman
301-827-3666
3752  04/2013 Pre-Amendment Device Determination Request (PDF)  (PDF - 677KB) DPLC
301-796-5770
3759  05/2014 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (PDF)  (PDF - 762KB) DRH
301-796-5790
3759  04/2011 Abbreviated Reports on Radiation Safety of Non Medical Ultrasonic Products (HTML)  (HTM - 0KB) DRH
301-796-5790
3760  06/2014 Guide for Preparing Product Reports for Medical Ultrasound Products (PDF)  (PDF - 771KB) DRH
301-796-5790
3801  06/2014 Guide for Preparing Initial Reports and Model Change Reports on Medical Ultraviolet Lamps and Products Containing Such Lamps (PDF)  (PDF - 1010KB) DRH
301-796-5790
3881  08/2014 Indications for Use (PDF)  (PDF - 1.7MB) Diane Garcia
301-796-6559

Page Last Updated: 07/15/2016
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