Robert (Bob) Hearn

Robert (Bob) Hearn

Epstein Becker & Green

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The LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests...more

4/8/2025  /  Administrative Procedure Act , Appeals , Chevron Deference , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Authority , Statutory Interpretation

A Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs

The order is in, and the LDT Final Rule is out. In May 2024, the U.S. Food & Drug Administration (“FDA” or the “Agency”) published its Final Rule establishing its regulatory framework over laboratory developed tests...more

4/1/2025  /  Final Rules , Food and Drug Administration (FDA) , Judicial Authority , Laboratory Developed Tests , Life Sciences , Medical Devices , Regulatory Authority , Statutory Interpretation

Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care [Video]

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...more

9/28/2023  /  Clinical Laboratories , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Pharmaceutical Industry

What’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory...

The Food and Drug Administration (“FDA” or “agency”) intends to issue a notice of proposed rulemaking in August 2023 that will “make explicit” that laboratory developed tests (LDTs) are devices under the federal Food, Drug,...more

6/30/2023  /  Biden Administration , Clinical Laboratories , Diagnostic Tests , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Life Sciences , Medical Devices , Notice of Proposed Rulemaking (NOPR) , Regulatory Oversight

New Guidance Clarifies Requirements for Onsite Workplace COVID-19 Testing

Important guidance regarding COVID-19 testing in the workplace was recently issued by the Centers for Medicare & Medicaid Services (“CMS”) in the form of Frequently Asked Questions regarding Over the Counter (“OTC”) Home...more

12/16/2021  /  CLIA , Coronavirus/COVID-19 , Corporate Counsel , Food and Drug Administration (FDA) , Virus Testing , Workplace Safety
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