Medical Devices

Public Workshop – Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers, April 1, 2014

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 Markers”.

The purpose of this workshop was 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 was 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:

This meeting was 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

Back to Top Arrow


Webcast

Back to Top Arrow


Agenda

Time

Subject

Name of Speaker
9:00-9:05WelcomeUwe Scherf, PhD
9:05-9:15OCET Welcoming RemarksRebecca S. Lipsitz, PhD
9:15-9:25CDRH Welcoming RemarksAlberto Gutierrez, PhD
9:25-9:45Enabling Sequence-based Technologies for Diagnostics: FDAs Division of Microbiology Perspective.John Hobson, PhD
9:45-10:00BREAK 
10:00-10:25Clinical Pathogen Genome SequencingLynn Bry, MD, PhD
10:25-10:50Current State of the Art for Reference Databases: Challenges and Feasibility StudiesTom Slezak
10:50-11:00BREAK 
11:00-11:25NIAID Genomics and Bioinformatics ProgramsVivien Dugan, PhD
11:25-11:50Pathogen Genomics at NCBIDavid J Lipman, MD
11:50-12:00Q&A (All Presentations) 
12:00-13:00LUNCH 
13:00-14:15Panel 1 – Clinical Applications:
Lynn Bry MD PhD, Joseph Campos PhD, Lauren Cowan PhD, Eric Donaldson PhD, Brittany Goldberg MD, Duncan MacCannell PhD, Uwe Scherf PhD, Julie Segre PhD
Steven Gitterman, MD
14:15-14:30BREAK 
14:30-15:45Panel 2 – Database/Informatics:
Eric Brown PhD, Chris Detter PhD, Vivien Dugan PhD, John Hobson PhD, Arifa Khan PhD, David Lipman MD, Tom Slezak
Tamara Feldblyum, PhD
15:45-16:30Wrap-up/ Q&AUwe Scherf, PhD

NIST Poster

Click here to download the NIST poster (PDF 260 KB)

Back to Top Arrow


Discussion Paper

Click here to download the discussion paper (PDF 574 KB).

Back to Top Arrow


Registration to Attend the Workshop:

Registration is closed as of March 25, 2014. Onsite registration will be available the morning of April 1, 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.

Back to Top Arrow


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, susan.monahan@fda.hhs.gov.

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, Heike.Sichtig@fda.hhs.gov.

Back to Top Arrow

Page Last Updated: 07/11/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.