Workshops & Conferences (Medical Devices) > Public Workshop - Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015

Workshops & Conferences (Medical Devices) > Public Workshop - Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015

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
• Federal Register Notice
• Discussion Paper
• Agenda
• Registration
• Contact Us

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

NIH Campus Visitor Information

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 Unique features of NGS Previous NGS clearances/approvals Justification for considering new approaches Description of possible frameworks
Session 1	Analytical Performance of NGS Tests
9:20–10:20	Panel 1 - Developing analytical and process standards What defines an NGS test Requirements for quality in NGS tests        Content of analytical standards (metrics) Content of process standards Role for software in evaluating analytical performance Hereditary vs somatic disease
10:20–10:40	Break
10:40–11:40	Panel 2 - Implementing analytical and process standards Who should be involved in development of standards How should they be implemented Modifications to tests Certification of conformance to 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 Evidence base for clinical validity Landscape of existing databases Database quality Evaluation of evidence contained in databases Interpretation as a process NGS and companion diagnostics
1:50–2:50	Panel 4 - Communication of evidence Communicating uncertainty When results should be reported How results should be reported
2:50–3:10	Break
Section 3	Regulatory Considerations
3:10–4:10	Panel 5 - Factors in considering the optimal regulatory approach for NGS What are the risks and benefits of new approaches compared to existing approaches? What measures should FDA take to monitor progress and impact? What incentives and disincentives will a new approach create for stakeholders? Will a new approach stimulate innovation?
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.

Attendance  In-Person   Webcast Title     Mr. Mrs. Ms. None First Name* Last Name *   M.D.     Ph.D. Email* Please enter Email again for verification : Phone Number*  (No dashes or spaces in phone numbers please) Company or Organization * Request to Comment * Do you wish to make a public comment?  Yes  No Brief description of topic:

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.