<searchTitle>Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses; Availability; Federal Register Vol. 74, Issue </searchTitle>
<granuleClass>NOTICE</granuleClass>
<accessId>E9-21725</accessId>
<agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
<agency order="2">Food and Drug Administration</agency>
<departmentDoc>Docket No. FDA-2009-D-0386</departmentDoc>
<billingCode>4160-01-S</billingCode>
<frDocNumber>E9-21725</frDocNumber>
<action>Notice.</action>
<summary>The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses." FDA is issuing this draft guidance to inform industry and agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for in vitro diagnostic devices intended for the detection or detection and differentiation of human papillomaviruses.</summary>
<dates>Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by December 8, 2009.</dates>
<contact>Kate Simon, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 5552, Silver Spring, MD 20993, 301-796-6204.</contact>
<tocSubject1>Draft Guidance for Industry and Food and Drug Administration Staff:</tocSubject1>
<tocDoc>Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses
, </tocDoc>
<emailRef>dsmica@fda.hhs.gov</emailRef>
<urlRef>http://www.fda.gov/cdrh</urlRef>
<urlRef>http://www.fda.gov/cdrh/guidance.html</urlRef>
<urlRef>http://www.regulations.gov</urlRef>