Medical Device Regulation, Compliance & Policy, Part 1: LDTs in Focus

In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner at Covington; and Susan Van Meter, President of the American Clinical Laboratory Association (ACLA). Together, they discuss the history of laboratory developed test (LDT) regulation; ACLA engagement with FDA and Congress on potential diagnostics reform legislation; FDA's subsequent LDT regulation and ACLA's  decision to initiate litigation; current issues facing laboratories and in vitro diagnostics manufacturers; how the rise of AI is impacting diagnostics; the potential for Congress to reengage on diagnostics regulation moving forward; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected]. Music by Dvir Silver from Pixabay.