The Food and Drug Administration (FDA) is announcing a public Workshop on Mobile Medical Applications Draft Guidance. The U.S. Food and Drug Administration on July 19, 2011 announced it is seeking input on its oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (“apps”) that are designed for…

The Food and Drug Administration (FDA) is announcing a public meeting entitled: “Recommendations Proposed in Institute of Medicine Report: ‘Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years.’” The purpose of the meeting is to encourage public comment on the recommendations proposed in the Institute of Medicine (IOM) report. Date,…

Stakeholder Meeting on MDUFA III ReauthorizationJuly 27, 2011, 1:40 – 4:00 PMHHS Humphrey Building, Washington, DC Room 325A Purpose To review status of MDUFA III negotiations. Participants FDA Malcolm Bertoni Office of the Commissioner (OC) Ashley Boam Center for Devices and Radiological Health (CDRH ) Nathan Brown Office of Chief Counsel (OCC) Kate Cook Center…

Date, Time and Location Agenda Registration Contacts Date, Time and Location The meeting will be held on September 7-9, 2011 from 9:00 a.m. to 5:00 p.m. and an optional session (see agenda) will be held on September 6, 2011 from 1:00 p.m. – 5:30 p.m. at the following location: FDA / White Oak Campus (building…

These diagnostic devices present several advantages, such as identifying potential disease etiology in situations where many different pathogens share a common clinical manifestation and the simultaneous detection of co -infections. However, establishing and validating the performance of these devices to make informed clinical and public health decisions pose significant scientific challenges. The purpose of the…

(October 1, 2011 through September 30, 2012) Greetings Registered Establishment: This letter is to notify you of the fiscal year 2012, (October 1, 2011-September 30, 2012), fee rates and payment procedures for medical device user fees payable to the United States Food and Drug Administration, (US FDA). This information was also announced in the Federal…

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Document issued on: August 9, 2011 This document supersedes “Herpes Simplex Virus Types 1 and 2 Serological Assays” dated April 3, 2007. The draft of this document was issued on September 28, 2010. For questions regarding this document contact Haja Sittana El Mubarak, Ph.D., Division of Microbiology Devices at 301-796-6193 or by email: [email protected]. U.S….

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