CDRH (DSMICA) Regulatory Manuals Page

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.

MANUAL	WEB SITE	3½" DISK FORMAT
Premarket Notification 510(k) Manual FDA 95-4158 (August 1995)	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 FDA 97-4224 (January 1997)	www.fda.gov/cdrh/manual/ivdmanul.html Updated Information: http://www.fda.gov/cdrh/devadvice/314.html http://www.fda.gov/cdrh/oivd/index.html	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 FDA 89-4203 (August 1989)	www.fda.gov/cdrh/dsma/470.pdf See also: http://www.fda.gov/cdrh/devadvice/33.html	Not Available
Medical Device Quality Systems Manual FDA 97-4179 (December 1996)	www.fda.gov/cdrh/dsma/gmpman.html	Wordperfect 6.1 (2) Disks
Medical Device Reporting (March 1997) FOD #987/40pg	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 (April 1999)	www.fda.gov/cdrh/manual/ireas.html or pdf	Adobe .pdf file
Medical Glove Guidance Manual FDA 99-4257 (July 1999)	www.fda.gov/cdrh/manual/glovmanl.pdf http://www.fda.gov/cdrh/dsma/135.html	Adobe .pdf file

MANUAL

WEB SITE

3½" DISK FORMAT

Premarket Notification 510(k) Manual
FDA 95-4158
(August 1995)

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
FDA 97-4224
(January 1997)

www.fda.gov/cdrh/manual/ivdmanul.html

Updated Information:
http://www.fda.gov/cdrh/devadvice/314.html
http://www.fda.gov/cdrh/oivd/index.html

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
FDA 89-4203
(August 1989)

www.fda.gov/cdrh/dsma/470.pdf

See also:
http://www.fda.gov/cdrh/devadvice/33.html

Not Available

Medical Device Quality Systems Manual
FDA 97-4179
(December 1996)

www.fda.gov/cdrh/dsma/gmpman.html

Wordperfect 6.1
(2) Disks

Medical Device Reporting
(March 1997)
FOD #987/40pg

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
(April 1999)

www.fda.gov/cdrh/manual/ireas.html or pdf

Adobe .pdf file

Medical Glove Guidance Manual
FDA 99-4257
(July 1999)

www.fda.gov/cdrh/manual/glovmanl.pdf
http://www.fda.gov/cdrh/dsma/135.html

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.)

CDRH Regulatory Manuals