 |
FDA Home Page | Search FDA
Site | FDA A-Z Index |
Contact FDA
FDA Forms Distribution
Page for
Center for Devices and Radiological Health (CDRH)
The forms provided by this web site are available in several formats. These formats include:
Adobe
Acrobat Portable Document Format (PDF) *
Microsoft Word 
Microsoft Excel 
WordPerfect 
Extensible Markup Language
Hypertext Markup Language (HTML) 
Filler Forms
| FDA Form # | Date | Title | Format | Paper Copy or Contact Info. |
|---|---|---|---|---|
| 2579 | 07/02 | Report of Assembly of a Diagnostic X-Ray System | Not Yet Electronic | PPF |
| 2767 | 12/03 | Notice of Availability of Sample Electronic Product | |
Debbie Perrell 301-594-4654 |
| 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 of Products Subject to Radiation Control Standards | |
Chris Colburn 301-827-7669 |
| 2891 | 03/02 | Initial Registration of Medical Device EstablishmentTHIS FORM MUST BE SUBMITTED IN TRIPLICATE | |
DSMA FAX 301-443-8818 |
| 2891a | 03/02 | Annual Registration of Medical Device Establishment | Not Yet Electronic | Bryan H.
Benesch 301-594-4591 Ext. 151 |
| 2892 | 03/02 | Medical Device Listing | |
DSMA FAX 301-443-8818 |
| 3147 | 12/03 | Application for a Variance From 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device | |
Debbie
Perrell 301-594-4654 |
| 3417 | 06/03 | Medical Device Reporting- Baseline Report- Part 1 {Instructions} | |
William Huff 301-594-3888 |
| 3419 | 06/03 | Medical Device Reporting Annual User Facility Report {Instructions} | |
William Huff 301-594-3888 |
| 3422 | 03/04 | Government Entity Declaration | |
Susan Bradt 301-594-3653 |
| 3427 | 01/03 | Supplemental Data Sheet | |
Marjorie Shulman 301-594-1190 |
| 3429 | 01/03 | General Device Classification Questionnaire | |
Marjorie Shulman 301-594-1190 |
| 3454 | 02/03 | Certification: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-827-5921 |
| 3455 | 02/03 | Disclosure: Financial Interest and Arrangements of Clinical Investigators | |
Leah W. Ripper 301-827-5921 |
| 3500 | 09/03 | MedWatch: FDA Medical Product Reporting Program {Instructions} | |
MEDWATCH 1-800-FDA-1088 |
| 3500A | 09/03 | MedWatch: FDA Medical Products Reporting Program - Mandatory {Instructions} |
|
MEDWATCH 1-800-FDA-1088 |
| 3514 | 12/03 | CDRH Submission Cover Sheet | |
Chris Colburn 301-827-7669 |
| 3541 | 12/02 | Premarket Notification [510(K)] Status Request and Response | |
Chris Colburn 301-827-7669 |
| 3601 | 04/03 | Medical Device User Fee Cover Sheet | |
David Wardrop Jr. 301-827-3512 |
| 3602 | 02/03 | MDUFMA Small Business Qualification Certificate | Not Yet Electronic | James Norman 301-827-6829 |
| 3608 | 06/04 | Medical Device Fellowship Program Student Application {Instructions} | |
Michelle Mattera 301-827-7969 |
1. To download PDF format: If Acrobat is not available on your PC, go to http://www.adobe.com/prodindex/acrobat/readstep.html.
2. By going to http://www.adobe.com/products/acrobat/access_onlinetools.html provides a set of free tools that allow visually disabled users to read documents in Adobe PDF format. These tools convert PDF documents into either HTML or ASCII text which can then be read by many screen reading programs.
3. Microsoft Word files can be viewed with that application or with a document viewer available free from the Microsoft Website: http://www.microsoft.com/downloads/details.aspx?FamilyID=0e56d944-38f6-4eb5-aca6-8bd280d5e6b1&DisplayLang=en.
Edition: October 29, 2004