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: 08/10/2023 11:30 AM

Requestor: Innovation Policy Solutions Requestor's Name: Megan Anderson Brooks Requestor's Client: Association for Molecular Pathology

Documents:

List of Documents
Association for Molecular Pathology Meeting Slides 8.9.23
AMPResponseFDACaseReportFinal
Senate HELP 2016 hearing transcript; Laboratory testing in the era of precision medicine
Comparison of Laboratory-Developed Tests and FDA-Approved Assays for BRAF, EGFR, and KRAS Testing - PMC
HHS-Legal-Memo-on-LDTs-by-Charrow-00864663

Attendees:

List of Attendees		Participation
•	Julie Wise - OMB	Teleconference
•	Ariel Seeley - FDA	Teleconference
•	Kevin Kho - FDA	Teleconference
•	Christina Zielke - HHS	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Mary Busch - FDA	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Elizabeth Hillebrenner - FDA	Teleconference
•	Sara Beardsley - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference
•	Mary Williams - Association for Molecular Pathology	Teleconference
•	Annie Scrimenti - Association for Molecular Pathology	Teleconference
•	Dr. Megan Anderson Brooks - Innovation Policy Solutions	Teleconference
•	Jennifer Leib - Innovation Policy Solutions	Teleconference
•	Dr. Eric Konnick - Association for Molecular Pathology	Teleconference
•	Dr. Monika Franco - Association for Molecular Pathology	Teleconference
•	Samantha Pettersen - Association for Molecular Pathology	Teleconference
•	Lindsey Trischler - Innovation Policy Solutions	Teleconference