Public Workshop - Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015
The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” The purpose of this workshop is to discuss and receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology.
Date, Time and Location:
This meeting will be held February 20, 2015, from 8:30 am to 5:00 pm. at the following location:
Natcher Center at the NIH Campus
9000 Rockville Pike
Bldg. 45, Auditorium
Bethesda, MD 20814
9000 Rockville Pike
Bldg. 45, Auditorium
Bethesda, MD 20814
The meeting will be webcast (registration required).
Agenda
Time | Event |
---|---|
8:30–8:35 | Introduction (FDA) |
8:35–8:45 | Comments by FDA Commissioner (M. Hamburg) |
8:45–8:50 | Comments by CDRH Center Director (J. Shuren) |
8:50–9:20 | Consideration of new regulatory approache
|
Session 1 | Analytical Performance of NGS Tests |
9:20–10:20 | Panel 1 - Developing analytical and process standards
|
10:20–10:40 | Break |
10:40–11:40 | Panel 2 - Implementing analytical and process standards
|
11:40–12:50 | Lunch |
Session 2 | Clinical Performance of NGS Tests |
12:50–1:50 | Panel 3 - Use of evidence and database curation
|
1:50–2:50 | Panel 4 - Communication of evidence
|
2:50–3:10 | Break |
Section 3 | Regulatory Considerations |
3:10–4:10 | Panel 5 - Factors in considering the optimal regulatory approach for NGS
|
4:10–5:10 | Public Comments |
5:10–5:15 | Summary and Next Steps |
Registration to Attend the Workshop
If you wish to attend this Workshop, you must register by close of business on February 12, 2015. 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.
If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, atsusan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.
Contact Us
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education 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:
David Litwack, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, rm. 5544, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6697, email: ernest.litwack@fda.hhs.gov.
David Litwack, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, rm. 5544, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6697, email: ernest.litwack@fda.hhs.gov.
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