View EO 12866 Meeting 0910-AI85

Title: Medical Devices; Laboratory Developed Tests

Agency/Subagency: 0910-HHS/FDA

Stage of Rulemaking: Final Rule Stage

Meeting Date/Time: 04/11/2024 10:00 AM

Requestor: American Society for Microbiology Requestor's Name: Amalia Corby

Documents:

List of Documents
Comments-to-FDA-on-Regulation-of-LDTs_Dec-2023

Attendees:

List of Attendees		Participation
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Carmine Leggett - OMB/OIRA	Teleconference
•	Libby Ashley - OMB/OIRA	Teleconference
•	Thomas Libert - DPC	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Elizabeth Kim - FDA	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Kevink Kho - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Max Chomas - FDA	Teleconference
•	Elizabeth Hillebrenner - FDA	Teleconference
•	Emily Ready - American Society for Microbiology	Teleconference
•	Amalia Corby-Edwards - American Society for Microbiology	Teleconference
•	Dr. Erin H. Graf - Mayo Clinic	Teleconference
•	Stefanie Rinehart - American Society for Microbiology	Teleconference
•	Paige Larkin - American Society for Microbiology	Teleconference
•	Erin Morton - American Society for Microbiology	Teleconference