LIVE: September 16, 2025 at 1:00 pm ET
The compliance landscape for clinical labs is entering a period of renewed scrutiny and uncertainty. Between the FDA's renewed interest in Research Use Only (RUO) labeling, questions surrounding software as a medical device, and potential shifts to CLIA regulation, it’s becoming harder to know what’s required now—and what’s next.
In this dynamic panel discussion, regulatory expert Julie Ballard, CLS, MLS(ASCP), and regulatory attorney Christine P. Bump will explore the key signals emerging from recent enforcement actions, shifting regulatory language, and key policy discussions. They will examine why many labs may be unaware of current compliance risks, and how software, specimen collection, and test labeling could soon be in the spotlight.
This conversation won’t offer easy answers, but it will help clarify the questions labs need to be asking now, and what they should be monitoring over the next 6–12 months.
After this session, participants will be able to:
Understand key compliance issues currently affecting clinical labs
Recognize potential risks related to test labeling, software, and specimen handling
Know what to watch for in upcoming regulatory changes over the next 6–12 months
Speakers
Christine P. Bump, BA, JD, MPH
Principal and founder of Penn Avenue Law & Policy, is an insightful regulatory attorney with two decades of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests. She advises laboratories, large corporations, and emerging companies with an awareness and understanding of their business and strategic goals. Christine has served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Before starting her firm, she practiced at Hyman, Phelps & McNamara, P.C. and in the Life Sciences group at Goodwin. Christine earned a BA from Sweet Briar College, an MPH from Emory University’s Rollins School of Public Health, and a JD from Emory University School of Law.
Julie Ballard
Principal of Carrot Clinical, is an independent clinical laboratory consultant with 25+ years of experience in helping organizations build and maintain world-class CLIA-certified and CAP-accredited clinical laboratories.
She assists clients with building, scaling, and maintaining clinical laboratories, quality systems, and regulatory programs; attaining CLIA certification, CAP and COLA accreditation, and California and New York state licenses; and launching novel laboratory-developed tests (LDTs).
Ballard is a licensed California Clinical Laboratory Scientist (CLS). Prior to founding Carrot Clinical, she played prominent roles in establishing quality management systems, regulatory compliance programs, and laboratory operations at ViroLogic (now Monogram Biosciences), Genomic Health (now Exact Sciences), Guardant Health, GRAIL, and Seer.