View EO 12866 Meeting 0910-AI85

Title: Medical Devices; Laboratory Developed Tests

Agency/Subagency: 0910-HHS/FDA

Stage of Rulemaking: Proposed Rule Stage

Meeting Date/Time: 09/26/2023 04:00 PM

Requestor: Carmen Group Requestor's Name: William Signer Requestor's Client: Academic Coalition for Effective Laboratory tests

Documents:

List of Documents
jamaoncology_kim_2017_br_170032-2
arpa_2018-0396-cp
FDA versus LDT 9-26-23
Tribe Clement White Paper 1-6-15
NY State Database Offers Glimpse Into Laboratory-Developed Testing Landscape_

Attendees:

List of Attendees		Participation
•	Bill Signer - Carmen Group Inc.	Teleconference
•	Ben Gibson - University of Chicago	Teleconference
•	Julie Wise - OMB/OIRA	Teleconference
•	Dr. Dara Aisner - University of Colorado School of Medicine	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Ariel Seeley - FDA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Elizabeth Hillebrenner - FDA	Teleconference
•	Sara Beardsley - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Siyeon Lee - FDA	Teleconference
•	Dr. Sheldon Campbell - Yale School of Medicine	Teleconference
•	Dr. Ian Hagemann - Washington University in St. Louis	Teleconference
•	Dr. Jonathan Nowak - Harvard University	Teleconference