Roche Custom Biotech 2025 Virtual Roundtable

LDT Regulation Post-FDA Final Rule: What’s Next for Labs and RUO Manufacturers?

Oct
28
2025

Date: October 28, 2025

Time: 1:00PM - 2:00PM (EST)

Location: Virtual

Join leading regulatory and diagnostics experts for a virtual round table hosted by Roche CustomBiotech that will examine the evolving oversight of laboratory-developed tests (LDTs) following a recent U.S. District Court ruling that limits FDA authority. The discussion will focus on what this shift means for research-use only (RUO) and investigational-use only (IUO) materials, exploring potential FDA enforcement trends, compliance strategies, and practical steps developers can take to stay ahead in a rapidly changing regulatory landscape. This is part of the roundtable series, "Navigating Shifting Diagnostics Regulations in the US and EU.

Mintz's Benjamin Zegarelli will be speaking on this roundtable.

Register for Event

Offices

  • Washington, DC

    • Professionals

  • Benjamin M. Zegarelli

    • Related Practices

  • FDA Regulatory

    • Related Industries

  • Health Care

    • Speakers

    Benjamin M. Zegarelli

    Benjamin M. Zegarelli

    Speaker

    Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.