View EO 12866 Meeting 0910-AI85

  Medical Devices; Laboratory Developed Tests

  0910-HHS/FDA

  Proposed Rule Stage

  09/07/2023 11:00 AM

  Association for Diagnostics and Laboratory Medicine   Vincent Stine


 
List of Documents
OIRA.FDA Medical Device Review
OIRA.CLIAC.letter
OMB.OIRA.Final
OIRA. groups opposed to VALID letter
OIRA.HHS.Memo Word Doc
OIRA.Tribe.White Paper LDTs
 
List of Attendees Participation
•   Dr. Dennis Dietzen, PhD  - NONE Teleconference 
•   Dr. Carmen Wiley, PhD  - NONE Teleconference 
•   Dr. jonathan Genzen, PhD  - NONE Teleconference 
•   Dr. Tina Lockwood, PhD  - NONE Teleconference 
•   Dr. Vincent Stine, PhD  - NONE Teleconference 
•   Mr. Chris Rorick  - NONE Teleconference 
•   Julie Wise  - OMB Teleconference 
•   Jennifer Nou  - OMB Teleconference 
•   Jane Wargo  - HHS Teleconference 
•   Ariel Seeley  - FDA Teleconference 
•   Carrie Doupnik  - FDA Teleconference 
•   Elizabeth Hillebrenner  - FDA Teleconference 
•   Kevin Kho  - FDA Teleconference 
•   Sheri Walker  - FDA Teleconference 
•   Mary Busch  - FDA Teleconference 
•   Siyeon Lee  - FDA Teleconference