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003 OCoLC;

005 20090427155625.0;

006 m d f ;

007 cr a||||||||||;

008 090427s2008 mdu o f000 0 eng d;

040 a| GPOc| GPOd| MvI;

049 a| ERE#;

074 a| 0499-T-02 (online);

086 0 a| HE 20.4802:R 32;

245 00 a| Guidance for industry and FDA staff :b| expedited review of premarket submissions for devices.;

246 30 a| Expedited review of premarket submissions for devices;

260 a| Rockville, MD :b| U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health :b| Center for Biologics Evaluation and Research,c| [2008];

300 a| 12 p. :b| digital, PDF file;

336 a| textb| txt2| rdacontent;

337 a| computerb| c2| rdamedia;

338 a| online resourceb| cr2| rdacarrier;

538 a| Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cdrh/mdufma/guidance/108.pdf ; current access is available via PURL.;

500 a| Title from PDF title page (viewed on Apr. 27, 2009).;

500 a| "February 29, 2008".;

500 a| GPO Cataloging Record Distribution Program (CRDP).;

650 0 a| Medical instruments and apparatusz| United Statesx| Evaluation.=| ^A3247;

710 2 a| Center for Devices and Radiological Health (U.S.)=| ^A119573;

710 2 a| Center for Biologics Evaluation and Research (U.S.)=| ^A368272;

856 40 u| https://purl.fdlp.gov/GPO/LPS111920;

949 a| Click on web addressw| asish| joyner94;

596 a| 1;

998 a| 1898577;

999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 1898577-1001l| JNETm| JOYNERr| Ys| Yt| JNE1DOu| 9/14/2009x| EDOCUMENTz| JERESOURCEo| .STAFF. jlhb;

Guidance for industry and FDA staff : expedited review of premarket submissions for devices.

Other author	Center for Devices and Radiological Health (U.S.)
Other author	Center for Biologics Evaluation and Research (U.S.)
Format	Electronic
Publication Info	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008]
Description	12 p. : digital, PDF file
Supplemental Content	https://purl.fdlp.gov/GPO/LPS111920
Subjects	Medical instruments and apparatus--United States. --Evaluation.

Portion of title	Expedited review of premarket submissions for devices
General note	Title from PDF title page (viewed on Apr. 27, 2009).
General note	"February 29, 2008".
General note	GPO Cataloging Record Distribution Program (CRDP).
Technical details	Mode of access: Internet at the FDA CBER Web site. Address as of 4/27/09: http://www.fda.gov/cdrh/mdufma/guidance/108.pdf ; current access is available via PURL.
GPO item number	0499-T-02 (online)
Govt. docs number	HE 20.4802:R 32

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Library	Location	Call Number	Status	Item Actions
	Electronic Resources	Access Content Online	✔ Available

Guidance for industry and FDA staff : expedited review of premarket submissions for devices.

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