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: 04/05/2024 11:00 AM

Requestor: Association of Pathology Chairs Requestor's Name: Priscilla Markwood

Documents:

List of Documents
CLIA Modernization FAQs (110923)
Article on LDT Quality & Impact on Care (2017)
Article on UCLA Monkeypox Test Submission (Oct 2023)
CLIA Modernization Legislative Text FINAL (110923)
OMB-OIRA FDA LDT Presentation (Final)
APC FDA Proposed Rule Response (120123)
ARUP Paper on FDA Rule Implications (MedRxiv-022824)
CLIA Modernization Side-by-Side (110923)

Attendees:

List of Attendees		Participation
•	Priscilla S. Markwood - Association of Pathology Chairs	Teleconference
•	Karen L. Kaul, MD - Association of Pathology Chairs	Teleconference
•	Lydia P. Howell, MD - Association of Pathology Chairs	Teleconference
•	Steven Kroft, MD - Association of Pathology Chairs	Teleconference
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Libby Ashley - OMB/OIRA	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Max Chomas - FDA	Teleconference
•	Rachel Park - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Anthony Ho - OPPR	Teleconference
•	Kevin Kho - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Sara Beardsley - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Marcy Busch - FDA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Elizabeth Kim - FDA	Teleconference
•	Cristina McLaughlin - FDA	Teleconference