View EO 12866 Meeting 0910-AI85

  Medical Devices; Laboratory Developed Tests


  Proposed Rule Stage

  08/04/2023 11:30 AM

  Strathmore Health Strategy   Cara Tenenbaum

List of Documents
The public health evidence for FDA oversight of laboratory developed tests 20 case studies 2015
Understanding the role of lab-developed tests in vitro diagnostics (PEW)
CSPI FDA letter
These Prenatal Tests Are Usually Wrong When Warning of Rare Disorders - The New York Times_from word
List of Attendees Participation
•   Julie Wise   - OMB Teleconference 
•   Elizabeth Ashley   - OMB Teleconference 
•   Joanne Davenport  -  OMB Teleconference 
•   Christina Zielke   - HHS Teleconference 
•   Ariel Seeley   - FDA Teleconference 
•   Sheri Walker   - FDA Teleconference 
•   Carrie Doupnik   - FDA Teleconference 
•   Eitan Bernstein   - FDA Teleconference 
•   Elizabeth Hillebrenner   - FDA Teleconference 
•   Kevin Kho   - FDA Teleconference 
•   Sara Beardsley  -  FDA Teleconference 
•   Peter Lurie   - Center for Science in the Public Interest Teleconference 
•   Ms. Cara Tenenbaum, JD  - Strathmore Health Strategy Teleconference 
•   Mr. Thomas Eagen  - National Center for Health Research Teleconference 
•   Ms. Stephanie Rogus  - Center for Science in the Public Interest Teleconference 
•   Ms. Patricia Kelmar  - US PIRG Teleconference