View Completed EO 12866 Meeting

Title: Medical Devices; Laboratory Developed Tests

Agency/Subagency: 0910-HHS/FDA

Stage of Rulemaking: Final Rule Stage

Meeting Date/Time: 03/18/2024 01:00 PM

Requestor: Association for Diagnostics and Laboratory Medicine Requestor's Name: Vincent Stine

Documents:

List of Documents
CHA_comments_LDT Proposed Rule
ARUP Public Comment Letter on LDTs
OMB.OIRA.final.3.18
hyman.legal analysis LDT PR

Attendees:

List of Attendees		Participation
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Libby Ashley - OMB/OIRA	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Etian Bernstein - FDA	Teleconference
•	Elizabeth Hillebrenner - FDA	Teleconference
•	Mary Busch - FDA	Teleconference
•	Max Chomas - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Sara Beardsly - FDA	Teleconference
•	Elizabeth Kim - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Scott Levy - OPPR	Teleconference
•	Catherine Hensly - OMB/VADH	Teleconference
•	Carmine Leggett - OMB/OIRA	Teleconference
•	Anthony Ho - OPPR	Teleconference
•	Dr. Dennis Dietzen - ADLM	Teleconference
•	Dr. Carmen Wiley - ADLM	Teleconference
•	Dr. Tina Lockwood - ADLM	Teleconference
•	Dr. Vincent Stine - ADLM	Teleconference
•	Mr. Chris Rorick - Polsinelli	Teleconference
•	Mr. Evan Fortman - ADLM	Teleconference
•	Dr. Patti Jones - ADLM	Teleconference