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: 03/22/2024 10:00 AM

Requestor: Center for Science in the Public Interest Requestor's Name: Stephanie Rogus

Documents:

List of Documents
CSPI comment on FDA proposed rule on LDTs
Pfeifer et al 2021
Patient group letter on FDA proposed rule
OMB meeting talking points_3.22.24
The Public Health Case for FDA Oversight of LDTs
PEW LDTs 2021

Attendees:

List of Attendees		Participation
•	Irene Ulrich - CSPI	Teleconference
•	Patricia Kelmar - PIRG	Teleconference
•	Diana Zuckerman - National Center for Health Research	Teleconference
•	Peter Lurie - CSPI	Teleconference
•	Cara Tenenbaum - Strathmore Health	Teleconference
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Libby Ashley - OMB/OIRA	Teleconference
•	Anthony Ho - OPPR	Teleconference
•	Stephanie Rogus - CSPI	Teleconference
•	Jane Wargo - HHS	Teleconference