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: 08/08/2023 10:00 AM

Requestor: Covington & Burling LLP Requestor's Name: Scott Danzis Requestor's Client: American Clinical Laboratory Association (ACLA)

Documents:

List of Documents
ACLA Letter to Shalanda Young and Topher Spiro 8-7-23

Attendees:

List of Attendees		Participation
•	Susan Van Meter - President, American Clinical Laboratory Association	Teleconference
•	William Morice, MD - President and CEO, Mayo Clinic Laboratories	Teleconference
•	Scott Danzis, JD - Partner, Covington & Burling	Teleconference
•	Ariel Seeley - FDA	Teleconference
•	Julie Wise - OMB	Teleconference
•	Elizabeth Ashley - OMB	Teleconference
•	Mary Busch - FDA	Teleconference
•	Catherine Oakar - DPC	Teleconference
•	Christina Zielke - HHS	Teleconference
•	Jane Wargo - HHS	Teleconference
•	Carrie Doupnik - FDA	Teleconference
•	Eitan Bernstein - FDA	Teleconference
•	Elizabeth Hillebrenner - FDA	Teleconference
•	Kevin Kho - FDA	Teleconference
•	Sara Beardsley - FDA	Teleconference
•	Sheri Walker - FDA	Teleconference