The FDA’s recent decision to classify Laboratory-Developed Tests (LDTs) as medical devices has had a profound impact on the industry. In the absence of any passed legislation in 2022, the FDA has taken a significant step to assert its authority and underscore the public health ramifications associated with various LDTs. Time is running out, as stakeholders have only until December 3, 2023, to express their opinions on this proposal. In our complimentary educational webinar, sponsored by Lumea and the DDX Foundation, FDA expert Ralph Hall addresses the following topics:
– Examining the primary arguments against the FDA’s oversight of LDTs
– Providing a comprehensive overview of the current regulatory landscape
– Highlighting key provisions relevant to LDT developers
– Discussing unresolved issues in the ongoing debate
– Presenting an update on the existing legislative environment
– Contrasting the proposed regulation with the last legislative draft
– Offering actionable strategies for engaging with stakeholders
While some may be for the regulatory change and others against it, this webinar is purely educational and not meant to convince listeners of one opinion or the other.
Hall sums the regulatory change up in a few words: “The key is they’re now considering LDTs to be manufacturers… under FDA authority.” To understand the full scope–the term manufacture includes the design, preparation, propagation, assembly, and processing.
“After several decades of enforcement discretion, they [the FDA] concluded that the increased complexity and the role of LDTs in medical care has changed to such an extent that it’s no longer good for public health… for the FDA to not have oversight [nor] good visibility,” explains Hall in the webinar.
Ralph Hall has decades of experience as a general counsel and substantial expertise in FDA matters, research and development, digital health, corporate compliance, intellectual property, and mergers and acquisitions. Hall is one of the nation’s foremost experts in drug medical device regulation and corporate compliance. He consults on FDA statutes and regulations, regulatory compliance, health care policy and legislation, and their application to the medical device industry.
Hall’s extensive background in drug and medical device regulation and corporate compliance has established him as a leading expert. He is currently a principal at Leavitt Partners. He previously served as counsel at Faegre Baker Daniels, as general counsel for Guidant CRM, and as the Chief Compliance Officer for Guidant. In addition to his professional roles, he holds the position of Professor of Practice at the University of Minnesota Law School. Hall earned his B.A. from Indiana University and a juris doctorate from the University of Michigan as a Weymouth Kirkland Scholar.
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