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: 04/19/2024 11:30 AM

Requestor: Duke University Health System Requestor's Name: Catherine Liao

Documents:

List of Documents
DUHS Comments of LDTs Final With Signatures

Attendees:

List of Attendees		Participation
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Rachel Park - FDA	Teleconference
•	Kevin Kho - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Max Chomas - FDA	Teleconference
•	Catherine Liao - Duke University Health System	Teleconference
•	Dr. Diana Cardona, MD - Duke University Health System	Teleconference
•	Dr. Mike Datto, MD - Duke University Health System	Teleconference
•	Elizabeth Kim - FDA	Teleconference