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Title In vitro diagnostic (IVD) device studies, frequently asked questions [electronic resource].

Imprint

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, [2010]

Connect to
Connect to https://purl.access.gpo.gov/GPO/LPS125166
Connect to https://www.fda.gov/media/71075/download

Copies

Location	Call No.	OPAC Message	Status
Axe Federal Documents Online	HE 20.4802:V 83/2	---	Available

Description	1 online resource (53 p.) : 1 chart.
Note	Title from PDF title page (viewed on Aug. 12, 2010).
	"This document supersedes "Guidance for FDA Staff: Regulating In Vitro Diagnostic Device (IVD) Studies," issued December 17, 1999."
	"Document issued on: June 25, 2010."
Bibliography	Includes bibliographical references: (p. 35-38).
Subject	Toxicity testing -- In vitro -- United States.
	Medical instruments and apparatus -- United States -- Testing.
Added Author	Center for Devices and Radiological Health (U.S.)
	Center for Biologics Evaluation and Research (U.S.)
Note	At head of title: Guidance for industry and FDA staff
Gpo Item No.	0499-T-02 (online)
Sudoc No.	HE 20.4802:V 83/2