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FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
---|---|---|---|---|
356h | 10/05 | Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use | CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
|
356v | 04/08 | New Animal Drug Application [VET] {Q&As on the Revised 356v Form} | Katherine Weld 240-276-8301 |
|
358v | 03/89 | NADA Folders (VET) | Not Yet Electronic | David Newkirk 301-827-6967 |
359v | 06/90 | INAD Folder (VET) | Not Yet Electronic | David Newkirk 301-827-6967 |
421 | 07/03 | Sample Accountability Record (ORA) | PPF | |
431 | 05/84 | Analyst Worksheet | PPF | |
431a | 05/84 | General Continuation Sheet | PPF | |
431d | 10/74 | Bacteriological Record | PPF | |
431e | 03/80 | Industrial Chemicals Worksheet | PPF | |
431f | 11/89 | Quantity of Contents | PPF | |
431g | 08/85 | Salmonella Record | William
Campanaro 301-827-1036 |
|
431h | 07/85 | Shigella Record | PPF | |
431i | 10/85 | Canned Food Continuation Sheet | PPF | |
431j | 08/85 | Botulism Continuation Sheet | William
Campanaro 301-827-1036 |
|
431k | 08/85 | Shellfish Bacteriological Record | William
Campanaro 301-827-1036 |
|
431m | 12/79 | Elemental Analysis Worksheet | PPF | |
433 | 06/82 | Tomato Inspection Report | Norman Fogg 301-827-5645 |
|
465 | 08/85 | Sample Summary | PPF | |
766 | 12/04 | Application for Authorization to Re label or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts | Carl R. Nielsen 301-443-6553 |
|
1533 | 10/01 | Results of Sediment Pad Grading | Norman Fogg 301-827-5645 |
|
1551 | 02/06 | Report of Sample Analysis | PPF | |
1551b | 01/93 | Report of Sample Analysis (Aflatoxins) | PPF | |
1570 | 04/78 | Summary of Bacteriological Results | William
Campanaro 301-827-1036 |
|
1570a | 04/78 | Bacteriological Definitions | William
Campanaro 301-827-1036 |
|
1571 | 04/06 | Investigational New Drug Application {Instructions} | CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
|
1572 | 05/06 | Statement of Investigator {Instructions-CDER} | CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
|
1609 | 03/86 | Research Project Record | William
Campanaro 301-827-1036 |
|
1609a | 03/86 | Research Progress Record | William
Campanaro 301-827-1036 |
|
1815 | 02/06 | Certificate/ Transmittal for an
Application |
Esther Lazar 301-436-1485 |
|
1932 | 09/03 | Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report | Glen A.
Peterson 301-827-0224 |
|
1932a | 09/03 | Veterinary Adverse Reaction, Lack of Effectiveness or Product Defect Report | Glen A.
Peterson 301-827-0224 |
|
1993 | 02/06 | Application for Permit to Ship or Transport Milk and/or Cream into US | Ester
Lazar 301-436-1485 |
|
1994 | 02/06 | Report of Tuberculin Tests of Cattle | Esther Lazar 301-436-1485 |
|
1995 | 02/06 | Report of Physical Examination of Cows | Esther Lazar 301-436-1485 |
|
1996 | 02/06 | Dairy Farm Sanitation Report | Esther Lazar 301-436-1485 |
|
1997 | 02/06 | Score Card for Sanitation Inspections of Milk Plants | Esther Lazar 301-436-1485 |
|
2096 | 03/04 | Regulation Certification for New Employee | Vincent Tolino 301-827-5514 |
|
2097 | 01/03 | Regulation Certification for Separating Employees | Vincent Tolino 301-827-5514 |
|
2098 | 11/02 | Regulation Certification for Special Government Employees | Vincent Tolino 301-827-5514 |
|
2196 | 07/87 | Laboratory Management Coding Sheet | PPF | |
2252 | 06/08 | Transmittal of Annual Report for Drugs and Biologics for Human Use | CBER MATT at 301-827-2000 CDER Drug Info at 301-796-3400 |
|
2253 | 06/08 | Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use | DDMAC 301-796-1200 |
|
2301 | 03/07 | Transmittal of Periodic Reports and Promotional Material for New Animal Drugs | Pamela Esposito 240-276-9067 |
|
2359 | 10/06 | Milk Plant Inspection Report | Robert Hennes 301-436-2175 |
|
2359a | 10/06 | Dairy Farm Inspection Report | PPF | |
2359b | 10/06 | Milk Plant Equipment Tests Report | Robert Hennes 301-436-2175 |
|
2359c | 10/08 | Manufacturing Plant Inspection Report | PPF | |
2359d | 10/06 | Report of Certification | PPF | |
2359g | 04/86 | Condensed & Dry-Milk & Whey Plant Inspection Report | PPF | |
2359h | 10/06 | Interstate Milk Shipper Check-Rating Report | PPF | |
2359i | 10/06 | Interstate Milk Shipper Report | PPF | |
2359j | 10/06 | Milk Sanitation Rating Report | PPF | |
2359k | 10/06 | Status of Raw Milk for Pasteurization | Robert Hennes 301-436-2175 |
|
2359l | 10/06 | Status of Milk Plants | Robert Hennes 301-436-2175 |
|
2359l-1 | 05/04 | Status of Condensed and Dry Milk Plants | Richard Eubanks 301-436-2174 |
|
2359m | 10/06 | Milk Plant, Receiving Station or Transfer Station NCIMS HACPP System Audit Report | Robert Hennes 301-436-2175 |
|
2359n | 10/06 | NCIMS HACPP System Regulatory Agency Review Report (To be included with all NCIMS HACCP Listings and FDA Audits) | Robert Hennes 301-436-2175 |
|
2359o | 10/06 | Permission for Publication Interstate Milk Shipper's Listing | Robert Hennes 301-436-2175 |
|
2399 | 10/06 | Dairy Plant Sampling - Raw & Pasteurized Milk | Robert Hennes 301-436-2175 |
|
2399a | 10/06 | Bulk Milk Hauler/Sampler Evaluation Report | Robert Hennes 301-436-2175 |
|
2399b | 10/06 | Milk Tank Truck Inspection Report | Robert Hennes 301-436-2175 |
|
2399c | 10/06 | Farm Bulk Tank Milk Sampling Inspection Record | Robert Hennes 301-436-2175 |
|
2399d | 10/06 | Dairy Plant - Milk Sample Collector Evaluation Record | Robert Hennes 301-436-2175 |
|
2400 | 03/01 | Cultural Procedures - General Requirements | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400d | 03/01 | MLEF Direct Microscopic Somatic Cell Count | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400a-1 | 03/01 | Milk Laboratory Evaluation Form: Spiral Plate Count Methods | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400b | 05/87 | MLEF Detention of Inhibitory Substances in Milk | Not Yet Electronic | Thomas E. Graham, Ph.D. 708-728-4114 |
2400b-1 | 03/01 | MLEF Detection of Inhibitory Substances in Milk Bacillus Stearothermophilus | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400b-3 | 03/01 | MLEF Detection of Inhibitory Substances in Milk Delvotest 5 Pack | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400d | 03/01 | MLEF Direct Microscopic Somatic Cell Count | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400 h-1 | 03/01 | MLEF Electronic Somatic Cell Count Foss 250/300/360/400 | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400h-2 | 03/01 | MLEF Electronic Somatic Cell Count Bentley Somacount 150/300/500 | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400h-3 | 03/01 | MLEF Electronic Somatic Cell Count Fossmatic 5000 | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400i | 03/01 | Pasteurized Milk Containers | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400j | 03/01 | Phosphatase Test | Thomas E. Graham, Ph.D. 708-728-4114 |
|
2400k | 03/01 | MLEF Flat Lid Methods | Thomas E. Graham,
Ph.D. 708-728-4114 |
|
2400l | 03/01 | MLEF Disintegration Method for Paper, etc. | Thomas E. Graham,
Ph.D. 708-728-4114 | |
2400m | 03/01 | MLEF Dairy Waters | Thomas E. Graham,
Ph.D. 708-728-4114 | |
2511 | 06/06 | Registration of Cosmetic Product Establishment {Instructions} | VCRP 301-436-1257 | |
2512 | 06/06 | Cosmetic Product Ingredient Statement {Instructions} | VCRP 301-436-1257 | |
2512a | 06/06 | Cosmetic Product Ingredient Statement{Instructions} | VCRP 301-436-1257 | |
2514 | 06/06 | Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation {Instructions} | VCRP 301-436-1257 | |
2541 | 10/08 | Food Canning Registration {Instructions} | LACF Coordinator LACF@FDA.HHS.GOV |
|
2541a | 10/08 | Food Process Filing For All Methods Except Low-Acid Aseptic {Instructions} | |
LACF Coordinator LACF@FDA.HHS.GOV |
2541c | 10/08 | Food Process Filing For Low-Acid Aseptic Systems {Instructions} | |
LACF Coordinator LACF@FDA.HHS.GOV |
2567 | 10/05 | Transmittal of Labels and Circulars | CBER MATT 301-827-2000 |
|
2579 | 06/08 | Report of Assembly of a Diagnostic X-Ray System | PPF | |
2589 | 08/01 | Inspection Summary - Bus Service Area Sanitation | PPF | |
2591 | 08/01 | Inspection Summary - Equipment Evaluation | PPF | |
2626 | 07/04 | New Drug Application/Biologic Licensing Application (Blue Folder) Archival | Not Yet Electronic | GPO |
2626a | 07/04 | New Drug Application/Biologic Licensing Application (Red Folder) Chemistry | Not Yet Electronic | GPO |
2626b | 07/04 | New Drug Application/Biologic Licensing Application (Yellow Folder) Pharmacology | Not Yet Electronic | GPO |
2626c | 07/04 | New Drug Application/Biologic Licensing Application (Orange Folder) Pharmacokinetic | Not Yet Electronic | GPO |
2626d | 07/04 | New Drug Application/Biologic Licensing Application (White Folder) Microbiology | Not Yet Electronic | GPO |
2626e | 07/04 | New Drug Application/Biologic Licensing Application (Tan Folder) Clinical Data | Not Yet Electronic | GPO |
2626f | 07/04 | New Drug Application/Biologic Licensing Application (Light Green Folder) Statistics | Not Yet Electronic | GPO |
2626h | 07/04 | New Drug Application/Biologic Licensing Application (Maroon Folder) Field Submission Chemistry | Not Yet Electronic | GPO |
2656 | 08/07 | Registration of Drug Establishment/Labeler Code Assignment {Instructions} THIS FORM MUST BE SUBMITTED IN TRIPLICATE | DRLS 301-210-2840 |
|
2657 | 02/08 | Drug Product Listing {Instructions} | DRLS drls@fda.hhs.gov or 301-210-2840 |
|
2658 | 08/07 | Registered Establishments Report of Private Label Distributors{Instructions} | DRLS drls@fda.hhs.gov or 301-210-2840 | |
2675 | 08/90 | Investigational New Drug Folder (Red) | Not Yet Electronic | GPO |
2675a | 10/86 | Investigational New Drug Folder (Green) | Not Yet Electronic | GPO |
2675b | 10/86 | Investigational New Drug Folder (Orange) | Not Yet Electronic | GPO |
2679 | 08/01 | Food Warehouse Inspection Report | Glen Johnson 301-827-2907 | |
2681 | 02/02 | Bakery Inspection Report | Glen Johnson 301-827-2907 | |
2682 | 08/01 | Beverage Plant Inspection Report | PPF | |
2684 | 04/02 | State Contract Monthly Food Report | Preet Sudhaker 301-827-2908 | |
2684a | 04/02 | State Contract Monthly Feed Establishment Report | Preet Sudhaker 301-827-2908 | |
2767 | 05/07 | Notice of Availability of Sample Electronic Product | DMQRP 240-276-3332 | |
2782 | 09/98 | Field Test Record Continuation Sheet | Stephen Toigo 301-827-2906 | |
2783 | 10/80 | Mobile Radiographic Systems Field Test Record | PPF | |
2784 | 10/80 | Above Table X-Ray Source Radiographic {2784.1-Pg1, 2784.2-Pg2, 2784.3-Pg3} Systems | PPF | |
2785 | 05/82 | Dental Radiographic Systems Field Test Record | PPF | |
2786 | 05/82 | Under Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record | Richard Barnes
301-827-2905 | |
2814 | 08/93 | Field Equipment Request | William Campanaro 301-827-1036 | |
2830 | 07/06 | Blood Establishment Registration and Product Listing | bloodregis@fda.hhs.gov | |
2877 | 12/03 | Declaration of Products Subject to Radiation Control Standards | DMQRP 240-276-3332 | |
2914 | 08/08 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Membership Summary | RDRC 301-796-2050 |
|
2915 | 08/08 | Radioactive Drug Research Committee (RDRC) Report on Research Use of Radioactive Drugs Study Summary | RDRC 301-796-2050 |
|
2966 | 10/88 | Food GMP Inspection Report | PPF | |
3038 | 03/07 | Interstate Shellfish Dealer's Certificate {ICSSL definition page link } | Charlotte Epps 301-436-2154 | |
3068 | 08/92 | Peak Kilovoltage Determination Field Test Record | PPF | |
3069 | 10/80 | Above Table X-Ray Source Fluoroscopic & Spot Film Systems Field Test Record | PPF | |
3070 | 08/92 | Mammography Systems Field Test Record | PPF | |
3071 | 04/01 | General Information Field Test Record | PPF | |
3131 | 08/01 | Contract Property Administration Completion Report | Mike McGrath 301-827-7105 | |
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 | |
3260 | 02/83 | C-Arm Fluoroscopic & Spot-Film Systems Field Test Record | PPF | |
3261 | 02/83 | Vertical Mount Cassette Holder Radiographic Systems Field Test Record | PPF | |
3297 | 04/01 | Head and Neck Radiographic Systems Field Test Record | PPF | |
3316 | 08/85 | Red - DRUG MASTER FILE ARCHIVAL BINDER | Not Yet Electronic | GPO |
3316a | 08/85 | Blue - DRUG MASTER FILE BINDER | Not Yet Electronic | GPO |
3331 | 01/09 | NDA Field Alert Report | Juliaette
Johnson 301-827-8928 |
|
3356 | 04/08 | Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) | tissuereg@fda.hhs.gov | |
3397 | 01/07 | User Fee Cover Sheet | Mike Jones 301-443-5151 | |
3410 | 10/01 | Confidential Financial Disclosure Report | Jenny Slaughter 301-827-5511 | |
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 | 01/09 | Supplemental Data Sheet | Marjorie Shulman 240-276-4040 |
|
3429 | 01/09 | General Device Classification Questionnaire | Marjorie Shulman 240-276-4040 |
|
3437 | 06/95 | CDER Pediatric Use Supplement | CDR 301-827-4210 | |
3448 | 09/07 | Medicated Feed Mill License Application | Jo W. Gulley 240-453-6858 | |
3452 | 04/03 | Export Certificate to Foreign Governments | Gloria Dunnavan 301-827-1166 | |
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 | |
3458 | 10/08 | Notice of Claimed Investigational Exemption (electronic) {Instructions} | Margaret Zabriski 240-276-9143 |
|
3463 | 07/00 | EDI Gateway Training Partner Agreement | Not Yet Electronic | Bill Taylor 301-827-6504 |
3479 | 03/05 | Notification for a Food Contact Substance Formulation | Francis Linn 301-436-1215 | |
3480 | 09/05 | Notification For New Use Of A Food Contact Substance | Francis Linn 301-436-1215 | |
3486 | 04/08 | Biological Product Deviation Report {Instructions} | CBER Program Surveillance Branch 301-827-6220 |
|
3487 | 10/08 | Notice of Final Disposition of Animals not Intended for Immediate Slaughter {Instructions} | Margaret Zabriski 240-276-9143 | |
3488 | 10/08 | Notice of Intent to Slaughter for Human Food Purposes {Instructions} | Margaret Zabriski 240-276-9143 |
|
3489 | 10/08 | Request for a Meeting or Teleconference {Instructions} | Margaret Zabriski 240-276-9143 | |
3500 | 01/09 | 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 | |
3501 | 07/08 | Domestic Seafood (HACCP) Report | Roshelle King 301-436-1416 | |
3502 | 07/08 | Importer Seafood HACCP Report | Roshelle King 301-436-1416 |
|
3503 | 09/07 | Food Additive Petition Submission | Maribeth LaVecchi 301-436-1211 | |
3504 | 09/07 | Color Additive Petition Submission | Maribeth LaVecchi 301-436-1211 | |
3511 | 03/07 | FDA LACF Inspection Report | Brian Hendrickson 317-226-6500 Ext. 104 | |
3511-2 | 03/07 | FDA Acidified Food Inspection Report | Brian Hendrickson 317-226-6500 Ext. 104 | |
3511-3 | 03/07 | Aseptic Processing & Packaging Report | Brian Hendrickson 317-226-6500 Ext. 12 | |
3511a | 03/07 | Processing in Steam in Still Retorts | Brian Hendrickson 317-226-6500 Ext. 104 |
|
3511b | 03/07 | Processing in Water in Still Retorts | Brian Hendrickson 317-226-6500 Ext. 104 | |
3511c | 03/07 | Processing in Steam in Continuous Agitating Retorts | Brian Hendrickson 317-226-6500 Ext. 104 |
|
3511d | 03/07 | Processing in Steam in Discontinuous Agitating Retorts | Brian Hendrickson 317-226-6500 Ext. 104 |
|
3511e | 03/07 | Processing in Water in Discontinuous Agitating Retorts | Brian Hendrickson 317-226-6500 Ext. 104 |
|
3511f | 03/07 | Processing in Steam in Hydrostatic Retorts | Brian Hendrickson 317-226-6500 Ext. 104 |
|
3511g | 03/07 | Processing in Cascading/Spray Water Retort | Brian Hendrickson 317-226-6500 Ext. 104 |
|
3511h | 03/07 | Processing in Steam-Air Retorts | Brian Hendrickson 317-226-6500 Ext. 104 | |
3511i | 03/06 | Processing in Other Unique Retort Systems | Brian Hendrickson 317-226-6500 Ext. 104 | |
3514 | 03/08 | CDRH Premarket Review Submission Cover Sheet | Bob Gatling 240-276-4015 | |
3536 | 07/07 | Protocol for Non-Clinical Laboratory and Effectiveness Studies{Instructions} | Margaret Zabriski 240-276-9143 |
|
3537 | 05/07 | Food Facility Registration {Instructions} | FDA Industry Systems Help Desk 800-216-7331 301-575-0156 |
|
3537a | 11/08 | Cancellation of Food Facility Registration {Instructions} | FDA Industry Systems Help Desk 800-216-7331 301-575-0156 |
|
3538 | 07/07 | Electronic Submission System Participant Password or Addition {Instructions} | Margaret Zabriski 240-276-9143 |
|
3539 | 04/06 | Review/Approval of Free Attendance at Widely Attended Gatherings (WAG) | Vincent Tolino 301-827-5514 | |
3540 | 05/07 | Prior Notice Submission {Instructions} | Prior Notice Center 866-521-2297 | |
3541 | 09/07 | Premarket Notification [510(K)] Status Request and Response | John Stigi 240-276-3150 EX 124 | |
3542 | 07/07 | Patent Information Submitted Upon and After Approval of An NDA or Supplement | Mary Ann Holovac 240-276-8971 | |
3542a | 07/07 | Patent Information Submitted With the Filing of An NDA, Amendment, or Supplement | Mary Ann Holovac 240-276-8971 | |
3543 | 12/03 | Certificate of a Pharmaceutical Product | Jocelyn Harris 301-827-8983 | |
3546 | 02/04 | Animal Drug User Fee Cover Sheet | Helio Chaves 301-827-3912 | |
3570 | 02/07 | Model Small Business Food Labeling Exemption Notice | SBusiness 301-436-2375 | |
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 | |
3610 | 10/03 | Contract Audit | Beverly Kent 716-541-0331 | |
3611 | 09/03 | Audit Report | Beverly Kent 716-541-0331 | |
3613 | 09/06 | Supplementary Information Certificate to Foreign Government Requests | Import/Export Team CBER 301-827-6201 or CDRH 240 276-0132 or CVM 240-276-0132 | |
3613a | 09/06 | Supplementary Information Certificate of Exportability Requests | Import/Export Team CBER 301-827-6201 or CDRH 240 276-0132 or CVM 240-276-0132 | |
3613b | 06/06 | Supplementary Information Certificate of a Pharmaceutical Product | Import/Export Team CBER 301-827-6201 or CDER 301-827-8940 or CVM 240-276-0132 | |
3613c | 09/06 | Supplementary Information Non-Clinical Research Use Only Certificate | Import/Export Team CBER 301-827-6201 or CDRH 240 276-0132 | |
3613d | 02/06 | Office of Cosmetics and Colors "Certificate" Export Application | Import/Export Team CFSAN 301-436-2776 | |
3613e | 02/06 | Food Export Certificate Application | Import/Export Team 301-436-2776 | |
3623 | 11/05 | Farm Investigation Questionnaire | Barbara Marcelletti 301-827-5635 | |
3623a | 11/05 | Additional Water Sources | Barbara Marcelletti 301-827-5635 | |
3623b | 11/05 | Additional Sets of Workers | Barbara Marcelletti 301-827-5635 | |
3625 | 10/98 | DSI Complaint Record | Joseph Salewski 301-796-3395 | |
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 | |
3642 | 07/07 | General Correspondence Report for CDRH Electronic Submissions | 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 | |
3649 | 07/07 | Accidental Radiation Occurrence Report | 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 | |
3664 | 07/07 | My Medicine Record {Instructions} | Cindi Fitzpatrick 301-796-3115 | |
3670 | 03/08 | MedSun (Medical Product Surveillance Network) | Marilyn Flack 240-276-2391 | |
3671 | 02/09 | Common EMEA/FDA Application for Orphan Medicinal Product Designation | Kathy Needleman 301-827-3666 |
|
3674 | 11/08 | Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) | Jarilyn Dupont 301-827-3360 |
|
3677v | 1/06 | Minor Species Index File (MIF) | Not Electronic Yet | Joan C. Gotthardt 240-276-9331 |
3717 | 4/08 | Report of Inspection for Compliance with 21 CFR 589.2000 | Shannon Jordre 240-276-9229 |
|
VAERS-1 | Vaccine Adverse Event Reporting System{Instructions} | VAERS 800-822-7967 |
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Edition: April 27, 2009
FDA/OIM
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