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Workshops & Conferences (Medical Devices) > Public Workshop - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015

Workshops & Conferences (Medical Devices) > Public Workshop - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015

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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 FDA’s detailed proposal is outlined in the draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory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
The meeting will be webcast.

Agenda

January 8, 2015

TimeSubjectName of Speaker
7:30 – 8:30Security screening and Registration
8:30 – 8:45WelcomeJeff Shuren, MD, JD
Director, CDRH
8:45 – 9:00Opening RemarksMargaret A. Hamburg, MD
Commissioner of Food and Drugs
9:00 – 9:30Overview of Proposed FrameworkKatherine Serrano
9:30 – 9:50Topic 1: Components of a Test and LDT Labeling ConsiderationsLiz Mansfield, PhD
9:50 – 10:10Topic 2: Clinical Validity/Intended UseAlberto Gutierrez, PhD
10:10 – 10:30Break
10:30 – 10:50Topic 3: Categories for Continued Enforcement DiscretionAbraham Tzou, MD
10:50 – 11:10Topic 4: Notification and Adverse Event Reporting (MDRs)Pamela Bradley, PhD
11:10 – 11:30Topic 5: Public Process for Classification and PrioritizationElizabeth Hillebrenner
11:30 – 11:50Topic 6: Quality System RegulationDavid Litwack, PhD
11:50 – 1:00Lunch Break
Topic 1: Components of a Test and LDT Labeling Considerations
1:00 – 2:00Public CommentMembers of the public who request to speak at the time of registration
2:00 – 2:45Panel DiscussionTBD
2:45 – 3:05Break
Topic 2: Clinical Validity/Intended Use
3:05 – 4:05Public CommentMembers of the public who request to speak at the time of registration
4:05 – 4:50Panel DiscussionTBD
4:50 – 5:00Wrap up

January 9, 2015

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

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