Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs

Throughout this series, we've talked about the growth of the direct access testing industry and the types of models developed to support the businesses that are using that type of testing. We've covered reimbursement considerations and physician ordering and specimen collection regulations. How does all of this come together to shape the future of the lab testing industry? On the final episode of our four-part series on direct access laboratory testing, Epstein Becker Green attorneys Bob Hearn, James Boiani, and Megan Robertson discuss licensing and operational considerations, as well as where the lab testing industry is headed.

 

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