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 11:00 AM

Requestor: Children's Hospital Association Requestor's Name: Jan Kaplan

Documents:

List of Documents
Childrens Hospital Association comments_LDT Proposed Rule
Examples of Pediatric LDTs
Childrens hospitals_additional information on false negative tests for OMB
Childrens National Financial Reimbursement for 10 common pediatric LDTs

Attendees:

List of Attendees		Participation
•	Marcy Busch - FDA	Teleconference
•	Elyse Greenwald - OMB/OIRA	Teleconference
•	Anthony Ho - OPPR	Teleconference
•	Libby Ashley - OMB/OIRA	Teleconference
•	Thomas Libert - DPC	Teleconference
•	Sara Beardsley - FDA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Cristina McLaughlin - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Kevin Kho - FDA	Teleconference
•	Nikki Kofsky - FDA	Teleconference
•	Rachel Park - FDA	Teleconference
•	Jill Aksamit - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Dr. Meghan Delaney, DO - Children's National Hospital	Teleconference
•	Ms. Jan Kaplan - Children's Hospital Association	Teleconference
•	Dr. Stephen Masters, MD - Children's Hospital of Philadelphia	Teleconference
•	Mr. Mark McGuire - Children's National Hospital	Teleconference
•	Ms. Sarah Guerrieri - Children's Hospital of Philadelphia	Teleconference