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Laboratories in the United States are facing a major regulatory landscape shift.

The U.S. Food and Drug Administration (FDA) has finalized a new rule ending its historical blanket enforcement discretion over laboratory developed tests (LDTs). What does this mean for labs going forward?

On this episode, Epstein Becker Green attorneys James Boiani, Rob Wanerman, and Megan Robertson lay out the new landscape, analyze existing and potential challenges, and identify key developments to watch for as this new regulatory era unfolds.

About the Diagnosing Health Care Podcast

The Diagnosing Health Care podcast series examines the business opportunities and solutions that exist despite the high-stakes legal, policy, and regulatory issues that the health care industry faces.

Trouble listening to this podcast? Please contact us at thisweek@ebglaw.com and mention whether you were at home or working within a corporate network. We'd also love to hear your suggestions for future episode topics.

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