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: 04/12/2024 10:00 AM

Requestor: McDermott Will & Emery LLP Requestor's Name: Mike Ryan Requestor's Client: Coalition for 21st Century Medicine

Documents:

List of Documents
C21_OMB Presentation_LDT Final Rule
Comments on FDA LDT Proposed Rule (final 12_4_2023)(1649413.11)

Attendees:

List of Attendees		Participation
•	Libby Ashley - OMB/OIRA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Eitan Bernstein - EPA	Teleconference
•	Elizabeth Hillebrenner - FDA	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Kevin Kho - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Rachel Park - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Marcy Busch - FDA	Teleconference
•	Elizabeth Kim - FDA	Teleconference
•	Max Chomas - FDA	Teleconference
•	Mike Ryan - McDermott	Teleconference
•	Joanne Davenport - FDA	Teleconference
•	Carmine Leggett - OMB/OIRA	Teleconference
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Brian Carey - Foley Hoag	Teleconference
•	Hannah Murphy - Coalition for 21st Century Medicine	Teleconference