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: 04/01/2024 10:00 AM

Requestor: American Clinical Laboratory Association Requestor's Name: Susan Van Meter

Documents:

List of Documents
ACLA Letter to OMB_DPC 3-5-2024

Attendees:

List of Attendees		Participation
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Cristina McLaughlin - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Marcy Busch - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Sara Bardsley - FDA	Teleconference
•	Jil Aksamit - HHS	Teleconference
•	Carmine Leggett - OMB/OIRA	Teleconference
•	Thomas Libert - DPC	Teleconference
•	Elizabeth Kim - FDA	Teleconference
•	Rachel Park - FDA	Teleconference
•	Ms. Amy Leiser - Covington & Burling, LLP	Teleconference
•	Ms. Susan Van Meter - American Clinical Laboratory Association	Teleconference
•	Mr. Scott Danzis - Covington & Burling, LLP	Teleconference