The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markersâ€.
The purpose of this workshop is to discuss the clinical and public health applications and performance validation of these devices, the quality criteria for establishing the accuracy of reference databases for regulatory use and ways to streamline clinical trials for microbial identification. This discussion is essential to establish the safety and effectiveness of high throughput sequencing devices when used to test human specimens or clinical isolates for the diagnosis of infectious diseases and detection of antimicrobial resistance markers.
- Date, Time and Location
- Federal Register Notice
- Webcast
- Agenda
- Discussion Paper
- Registration
- Contact Us
Date, Time and Location:
This meeting will be held April 1, 2014, beginning at 9:00 a.m. at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503A (the Great Room)
Silver Spring, MD, 20993
FDA Campus Information
Webcast
This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on March 25, 2014.
Webcast participants will be sent technical system requirements after registration and will be sent connection access information after March 25, 2014. If you have never attended a Connect Pro event, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit: http://www.adobe.com/go/connectpro_overview.Â
Agenda
Registration to Attend the Workshop:
If you wish to attend this Workshop, you must register by close of business on March 25, 2014. There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
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Contact Us
If you require special accommodations due to a disability, or need additional information regarding registration, please contact: Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5661, FAX: 301-847-8142, [email protected].
For questions regarding workshop content please contact: Heike Sichtig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, [email protected].
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