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July 11, 2025
Testing With Confidence: CLSI's Virtual Event Guiding Laboratories Through Regulatory Shifts
The Situation:
In May 2024, the US Food and Drug Administration (FDA) issued a final rule declaring its intent to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This move aimed to bring LDTs under direct FDA oversight, ensuring they meet the same stringent requirements as other medical devices, including premarket approval and quality management standards. The oversight was set to phase in over four years, starting in May 2025.
The Situation:
In May 2024, the US Food and Drug Administration (FDA) issued a final rule declaring its intent to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This move aimed to bring LDTs under direct FDA oversight, ensuring they meet the same stringent requirements as other medical devices, including premarket approval and quality management standards. The oversight was set to phase in over four years, starting in May 2025.
However, in March, a federal judge in the Eastern District of Texas vacated the FDA’s final rule, declaring that the agency had overstepped its authority by attempting to regulate LDTs as medical devices. The court held that LDTs constitute a professional service rather than a tangible product, placing them outside the FDA’s jurisdiction. Consequently, the FDA’s prior ruling was vacated, and LDTs are not required to comply with its provisions.
With the continuing ambiguity regarding LDT oversight, many medical laboratories and manufacturers remain uncertain about what protocols to follow and standards to uphold. As a result, they face challenges in producing LDTs that meet ethical and safety standards.
The Solution:
Testing With Confidence was a virtual half-day event designed to empower laboratorians, manufacturers, and health care professionals through education, discussion, and collaboration. The event featured expert-led Learning Labs and emphasized the importance of relying on CLSI standards to navigate the evolving regulatory landscape.
A dynamic panel discussion featuring event co-chairs Dr. Mindy Nye, PhD (LabCorp) and Mario Wijker (RAQAIVD) plus guests Dr. Tim Stenzel, MD, PhD (Grey Haven LLC, previously FDA), and Shannon Bennett, MS, MBA brought together leading voices in laboratory medicine, who provided insights from diverse perspectives across the health care landscape. Live Q&A segments followed each session, allowing participants to pose questions in real time and receive practical guidance.
"I would characterize the FDA LDT Final Rule as both a challenge and an opportunity," said Dr. Nye. "Doing nothing is often seen as more optimal than the strain of change, but the reality is, when you get pushed, you usually get to a better place."
The event featured several key components, including:
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Expert-Led Learning Labs: In-depth presentations on topics such as Evaluation Protocol Framework, Establishing Acceptance Criteria, and Quality System Implementation, providing actionable insights from subject matter experts.
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Panel Discussion with Industry Leaders: Energetic discussions on navigating regulatory change, the impact of artificial intelligence on laboratory efficiency, and innovative approaches to compliance and quality assurance, offering diverse perspectives from industry leaders.
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Live Q&A Sessions: Real-time interactions that allowed attendees to ask specific questions and receive direct guidance from panelists, clarifying uncertainties and providing tailored advice for their unique laboratory environments.
Outcome:
CLSI’s Testing With Confidence event attracted a strong and diverse audience, with over 87% of registrants participating live during the event, and additional viewers accessing sessions on-demand. The event drew nearly equal participation from CLSI members and non-members, showing broad interest across laboratorians, manufacturers, and regulatory experts.
Engagement and satisfaction were exceptionally high:
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97% of respondents rated the event as Good or Excellent (Top 2 box%), with 50% choosing Excellent
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100% agreed the content was relevant, and 97% found it valuable
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94% reported they felt more confident navigating regulatory uncertainty because of the event.
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33% of respondents represented hospitals or health services and 34% from industry
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Most participants were mid-career professionals, reflecting a mature and impact-ready audience.
The presentations on validation and quality control were excellent. The Quality Management Systems (QMS) presentations were new and helpful information. Webinars from CLSI would be a great boon for that community.
Overall, participants left the event feeling better equipped to navigate regulatory ambiguity following the vacating of the FDA’s LDT Final Rule. According to post-event survey results, 94% of respondents reported increased confidence in navigating the LDT landscape.
"During times of regualtory change, it's important to understand the significance of standards, standard guidelines, and tolls that are developed through consensus, " said CLSI CEO Barbara Jones. "In the case of CLSI, we have been here and will continue to be here through all the changes and regulations."
The overwhelmingly positive response affirmed CLSI’s reputation as a trusted source of guidance and a “lighthouse in the storm” during times of regulatory uncertainty. The event’s blend of expert speakers, panel discussions, and in-depth Learning Labs solidified CLSI’s position as a vital resource, particularly for laboratorians navigating regulations from entities like the Centers for Medicare & Medicaid Services (CMS) and the College of American Pathologists (CAP).
This feedback revealed a growing need for follow-up programming, with participants expressing interest for more in-depth explorations of quality management systems (QMS), risk management, and best practices in LDT development. CLSI is excited to build on this success with future events and educational content that address these specific needs.
Impact:
Advancing Lab Quality Through Education
CLSI’s continued emphasis on education plays a vital role in helping laboratories adapt to regulatory changes while strengthening their commitment to quality and patient care.
"CLSI resources and webinars and websites are really starting to be a repository of content and also potential expertise so that we can continue to live in that continual improvement and feedback environment and do the right thing and best thing for patient care," said Dr. Nye.
By fostering an environment of shared knowledge and continual growth, CLSI empowers laboratorians to keep pace with shifting regulations while thriving within them.
With 33% of attendees from hospitals or health services, and strong attendance of 34% from industry, the event brought together a diverse mix of healthcare and diagnostic professionals. This strong representation, particularly from mid-career practitioners, ensured the event reached those most likely to influence operational and strategic decisions within the laboratory. As a result, these individuals are now better equipped to drive positive change and improve patient care in their respective organizations.
The Testing With Confidence event solidifies CLSI’s position not only as a standards body, but as a responsive, supportive educational partner. The demand for more content, follow-up programming, and deeper dives into topics like QMS opens the door for future engagement, ongoing learning, and greater trust in CLSI’s leadership role.
"CLSI is more than our standards documents. The CLSI community offers the chance to be a part of a worldwide coalition that is committed to laboratory excellence that benefits all patients," said Barbara Jones.
As the laboratory landscape continues to evolve rapidly, the demand for timely standards-driven education has never been greater. Testing With Confidence equips laboratory professionals with the knowledge and tools to navigate complex regulatory shifts, while fostering a global community dedicated to advancing laboratory quality and patient care.
By supporting future events, sponsors become vital partners in this mission, helping to elevate laboratory standards, inspire innovation, and improve outcomes worldwide. Interested in being a part of these solutions? We invite you to join us in championing excellence in laboratory science by attending, contributing to, or sponsoring the next CLSI education event. Together, we can shape the future of diagnostic testing with confidence, clarity, and care, keeping the patient at the forefront!
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