View EO 12866 Meeting 0910-AI85

  Medical Devices; Laboratory Developed Tests

  0910-HHS/FDA

  Final Rule Stage

  04/04/2024 11:00 AM

  Children's Hospital Association   Jan Kaplan


 
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
 
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