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CDRH Regulatory Manuals |
Food and Drug Administration
Center for Devices and Radiological Health (CDRH)
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
CDRH has published several guidance documents to assist medical device manufacturers in complying with the Food, Drug and Cosmetic Act. Listed below are the major resource manuals and their availability from CDRH. Instructions for obtaining copies from the various media is included on the following page.
Instructions for downloading the PDF reader
MANUAL |
WEB SITE |
3½" DISK FORMAT |
---|---|---|
Premarket Notification 510(k) Manual |
www.fda.gov/cdrh/manual/510kprt1.html Updated information: http://www.fda.gov/cdrh/devadvice/314.html |
Wordperfect 6.1 |
In Vitro Diagnostic Devices for 510(k) Submissions |
www.fda.gov/cdrh/manual/ivdmanul.html Updated Information: |
Wordperfect 6.1 |
Instructions for Medical Device Registration and Listing
Forms FDA 2891, 2891a, and 2892 (October 1999) FOD #12/27pg |
www.fda.gov/cdrh/dsma/rlman.html |
Not Available |
Labeling |
www.fda.gov/cdrh/dsma/470.pdf See also: http://www.fda.gov/cdrh/devadvice/33.html |
Not Available |
Medical Device Quality Systems Manual |
Wordperfect 6.1 |
|
Medical Device Reporting |
www.fda.gov/cdrh/manual/mdrman.html
or pdf Updated information: http://www.fda.gov/cdrh/devadvice/351.html |
Word 7.0 |
Regulation of Medical Devices: Background Information for Foreign Officials |
Adobe .pdf file |
|
Medical Glove Guidance Manual |
www.fda.gov/cdrh/manual/glovmanl.pdf |
Adobe .pdf file |
Additional Guidance Documents - Other guidance documents can be obtained by searching the Good Guidance Document (GGP) database on the Internet at http://www.fda.gov/cdrh/guidance.html
Facts-On-Demand (FOD) - The CDRH F-O-D system will automatically fax a system index or a document to your fax machine. Dial 800-899-0381 or 301-827-0111 from a touch tone phone and follow the instructional prompts.
Obtaining copies from DSMICA - To request hardcopies of manuals or copies on 3 ½" disk, mail or fax DSMICA Publications. Provide the title of the manual, format (hardcopy or disk), and your complete mailing address. The manuals are available at no cost from DSMICA. (Please note that the Quality System manual is only available on disk from DSMICA.)
Food and Drug Administration
Center for Devices and Radiological Health (CDRH)
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
1350 Piccard Drive (HFZ-220)
Rockville, Maryland 20850
Fax: 301-443-8818
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