Jonathan Genzen, MD, PhD (left), chief medical officer and senior director of governmental affairs, will lead the webinar, and Jonathan Carr, JD (right), compliance officer, will moderate a Q&A session.
ARUP Laboratories will host a webinar on November 29 at 11 a.m. for clients, the media, and others to discuss the FDA’s proposed rule to regulate laboratory-developed tests as medical devices. Jonathan Genzen, MD, PhD, ARUP’s chief medical officer and senior director of governmental affairs, will present the challenges to labs and the complications for patients and providers if the rule is enacted. Genzen will then answer questions from participants, and Jonathan Carr, JD, ARUP’s compliance officer, will moderate the Q&A session.
Genzen will address patient safety concerns, test availability, and the impact on innovation. ARUP experts have said the proposed rule is a threat to clinical and academic laboratories, and if enacted, may force laboratories to stop offering some tests, which could disproportionately affect patients with rare diseases.
The FDA announced the proposed rule at the end of September and declined to extend the 60-day public comment period, despite requests from ARUP and dozens of other industry partners, many of whom have also publicly opposed the rule.
ARUP is asking participants to register in advance for the webinar and to submit questions to help shape the conversation to address attendees’ main concerns. The company’s goal is to increase understanding of this complex issue ahead of the December 4 deadline for public comment.
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