Public Workshop - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015

The purpose of this workshop is to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity for public comment. FDA’s detailed proposal is outlined in the draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” issued October 3, 2014.

The purpose of the workshop is to obtain feedback from all stakeholders on FDA’s proposal so that it can be refined in the best interest of public health.

Date, Time and Location

This meeting will be held January 8-9, 2015, beginning at 8:30am 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.

Agenda

January 8, 2015

Time	Subject	Name of Speaker
7:30 – 8:30	Security screening and Registration
8:30 – 8:45	Welcome	Jeff Shuren, MD, JD Director, CDRH
8:45 – 9:00	Opening Remarks	Margaret A. Hamburg, MD Commissioner of Food and Drugs
9:00 – 9:30	Overview of Proposed Framework	Katherine Serrano
9:30 – 9:50	Topic 1: Components of a Test and LDT Labeling Considerations	Liz Mansfield, PhD
9:50 – 10:10	Topic 2: Clinical Validity/Intended Use	Alberto Gutierrez, PhD
10:10 – 10:30	Break
10:30 – 10:50	Topic 3: Categories for Continued Enforcement Discretion	Abraham Tzou, MD
10:50 – 11:10	Topic 4: Notification and Adverse Event Reporting (MDRs)	Pamela Bradley, PhD
11:10 – 11:30	Topic 5: Public Process for Classification and Prioritization	Elizabeth Hillebrenner
11:30 – 11:50	Topic 6: Quality System Regulation	David Litwack, PhD
11:50 – 1:00	Lunch Break
Topic 1: Components of a Test and LDT Labeling Considerations
1:00 – 2:00	Public Comment	Members of the public who request to speak at the time of registration
2:00 – 2:45	Panel Discussion	TBD
2:45 – 3:05	Break
Topic 2: Clinical Validity/Intended Use
3:05 – 4:05	Public Comment	Members of the public who request to speak at the time of registration
4:05 – 4:50	Panel Discussion	TBD
4:50 – 5:00	Wrap up

January 9, 2015

Time	Subject	Name of Speaker
7:00 – 8:00	Security screening and Registration
8:00 – 8:10	Welcome and Announcements	TBD
Topic 3: Categories for Continued Enforcement Discretion
8:10 – 9:10	Public Comment	Members of the public who request to speak at the time of registration
9:10 – 9:55	Panel Discussion	TBD
9:55 – 10:15	Break
Topic 4: Notification and Adverse Event Reporting (MDRs)
10:15 – 11:15	Public Comment	Members of the public who request to speak at the time of registration
11:15 – 12:00	Panel Discussion	TBD
12:00 – 1:00	Lunch Break
Topic 5: Public Process for Classification and Prioritization
1:00 – 2:00	Public Comment	Members of the public who request to speak at the time of registration
2:00 – 2:45	Panel Discussion	TBD
2:45 – 3:05	Break
Topic 6: Quality System Regulation
3:05 – 4:05	Public Comment	Members of the public who request to speak at the time of registration
4:05 – 4:50	Panel Discussion	TBD
4:50 – 5:00	Wrap up

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on December 12, 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.

If you wish to make an oral presentation during any of the open comment sessions at the meeting you must indicate this at the time of registration. FDA requests that presentations focus on the areas defined in the Federal Register Notice. You should also identify which discussion topic you wish to address in your presentation and you must submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. In order to keep each open session focused on the discussion topic at hand, each oral presentation should address only one discussion topic. FDA will do its best to accommodate requests to speak.

Attendance	In-Person Webcast
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Expertise	If you are requesting to speak, please submit a brief statement of experience or expertise.

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: Allen Webb, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Bldg 66, rm 5675, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-4217, LDTframework@fda.hhs.gov