In this free webinar, gain insights into how regulatory guidance can help in vitro diagnostic (IVD) developers proactively navigate uncertainty and mitigate potential financial, compliance and operational risks. Attendees will learn about the FDA's proposed rule to regulate laboratory-developed tests (LDTs) as IVDs and the FDA's reclassification for high-risk IVDs. The featured speakers will discuss key changes introduced by the EU In Vitro Diagnostics Regulation (IVDR). The speakers will also share insights into the current progress on the transition to EU IVDR compliance.
TORONTO, March 18, 2024 /PRNewswire-PRWeb/ -- In vitro diagnostic (IVD) testing has become a cornerstone of modern medicine, with an estimated 70 percent of medical decisions made based on laboratory test results. Given the vital role IVDs play in guiding care, regulatory agencies frequently review approval requirements, and the regulatory frameworks governing these devices are constantly evolving.
The issuance of new regulations, guidance documents and regulatory proposals makes it critically important for IVD developers to proactively navigate uncertainty so that they are adequately prepared to mitigate the potential financial, compliance and operational risks that may surface in a dynamic regulatory environment.
In this webinar, the expert speakers will cover changes that have been proposed or implemented in the US and European Union (EU) IVD regulations and provide strategies for developers to adapt to the ever-changing landscape.
Register for this webinar today to gain insights into how regulatory guidance can help IVD developers proactively navigate uncertainty and mitigate potential financial, compliance and operational risks.
Join Charlie Chrisawn, Executive Director, Diagnostics, Premier Research; and Michael Edwards, Sr. Director, Regulatory Affairs, MedTech, Premier Consulting, for the live webinar on Friday, April 5, 2024, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit IVD Survival Guide: Navigating Uncertainty in the US and European IVD Regulatory Landscape.
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