View EO 12866 Meeting 0910-AI85

Title: Medical Devices; Laboratory Developed Tests

Agency/Subagency: 0910-HHS/FDA

Stage of Rulemaking: Proposed Rule Stage

Meeting Date/Time: 08/04/2023 11:30 AM

Requestor: Strathmore Health Strategy Requestor's Name: Cara Tenenbaum

Documents:

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

Attendees:

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