Added transcripts for Public Workshop – Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8

The purpose of this workshop was 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 FDA’s detailed proposal is outlined in the draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory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 was 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
• Federal Register Notice
• Webcast
• Transcripts
• Presentations
• Agenda
• Registration
• Contact Us

Date, Time and Location

• NIH Campus Visitor Information

The meeting will be webcast.

Webcast

• Day 1
• Day 2

[email protected] so that we may open your slot to our waitlist.

If you would like to be put on a waitlist for possible in-person attendance or register for the webcast, please e-mail [email protected].

Note that FDA is no longer scheduling public comment slots. All who registered to speak by the deadline have been notified of the date, time, and duration of their slot. Any individuals who did not register to speak in a public comment session may sign up on-site to speak during a general session in the afternoon of January 9, 2015. The duration of their speaking time will depend on the number of interested parties, but will not exceed the time given to advance registrants. Slides cannot be accomodated for on-site speaking registrations.

[email protected].

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, [email protected]