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: 04/04/2024 03:00 PM

Requestor: Coalition for Innovative Laboratory Testing Requestor's Name: Morgan Mills

Documents:

List of Documents
OIRA Meeting Apr. 2024 Final

Attendees:

List of Attendees		Participation
•	Cristina McLaughlin - FDA	Teleconference
•	Thomas Libert - DPC	Teleconference
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Marcy Busch - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Rachel Park - FDA	Teleconference
•	Max Chomas - FDA	Teleconference
•	Libby Ashley - OMB/OIRA	Teleconference
•	Ron Baker - Creative Micro Tech	Teleconference
•	Mr. David Liss - Bio Reference Laboratories	Teleconference
•	Greg Stein - NONE	Teleconference
•	Linwood Rayford - SBA Advocacy	Teleconference
•	Amanda Elam - Galaxy Diagnostics NC	Teleconference
•	John Compton - Self	Teleconference
•	Matt Henken - Van Scoyoc Associates	Teleconference
•	Cha-Mei Tang - NONE	Teleconference
•	Jonathan Cohen - 20 20 Gene Systems	Teleconference
•	Gail Javitt - Clemens and MacNamara	Teleconference
•	Morgan Mills - Coalition for Innovative Laboratory Testing	Teleconference