Life sciences regulatory & compliance partner Greg Levine and counsel Beth Weinman will present at the MassMEDIC Regulatory Roundup event in Boston on Nov. 13.
On the panel entitled “Laboratory Developed Tests (LDT) and In Vitro Diagnostics as Regulated Medical Devices,” Greg and Beth will address topics including the LDT rule’s implementation provisions, litigation challenging the rule, and post-election implications for the future of the LDT rule or any legislation that would clarify FDA’s authority over LDTs. It will also cover the potential implications of the U.S. Supreme Court’s Loper Bright ruling for device companies that might consider challenging an FDA legal interpretation.
MassMEDIC is an association supporting the medical technology industry in New England focused on public policy and innovation development.
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