Be Prepared for FDA Oversight
NEW! CLSI Perspective
The FDA Ruling on LDTs:
Taking Control of What's in Your Control
Since the final FDA ruling on Laboratory Developed Tests was published on 06 May 2024, there has been a great deal of discussion around the interpretation and implications of the new oversight. The final ruling declares the FDA’s authority to regulate laboratory developed tests (LDTs) as medical devices under the Food, Drug, and Cosmetic Act (FDCA) and phases out the discretionary enforcement that has been in place since the law was first enacted in 1976.
For 60 years CLSI has served as a trusted resource for laboratories, and we're here for them now – with the guidance, tools, and resources to ensure your lab is prepared. Download the report below for more information about how to navigate these new requirements.
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Upcoming Webinars | Register today for these upcoming webinars
CLSI On Demand: LDT Webinar
LDT Foundations Webinar Series: Exploring Standards that Support LDT Developers
Join CLSI for this webinar series dedicated to the stages of FDA's Final Rule on Laboratory Developed Tests (LDTs). Register for this first webinar and receive access to the entire series that will provide practical guidance, resources, and vital information for laboratories. Once you are registered for the series, you will receive notifications about new webinars that are released, all on-demand recordings, and webinar slides. CLSI will update this series frequently with new webinar dates, topi
CLSI Regulatory Webinar
Streamline the FDA Approval Journey: A Panel Discussion with the FDA, CLSI, and Abbott Laboratories
Navigating the FDA device approval and clearance process can be daunting. However, the appropriate use of consensus standards can greatly reduce the burden for the conformity assessment elements of medical device submissions. By using declarations of conformity (DOC), particularly with FDA-recognized standards, device developers and manufacturers can streamline submission preparation. The session will provide direction on how stakeholders can – and should – contribute to the development of conse
Manage Regulatory Requirements With the Newly Updated Method Navigator Tool
As a member of the IVD community, your test methods are subject to myriad regulatory requirements. It can be difficult to stay up-to-date or know which guidance to follow. CLSI’s newly updated Method Navigator, a comprehensive resource that maps our specific guidance to meet regulatory requirements, was built to help those who develop both IVDs and LDTs. Streamlined navigation to newly published revisions of CLSI documents including EP19, EP12, EP25, QMS17, and QMS18 is one key update that we encourage you to take advantage of!
Open Volunteer Opportunity:
Laboratory-Developed Test (LDT)
Final Rule Advisory Group
The FDA released the LDT Final Rule on 29 April 2024 and officially published it on 6 May 2024. The Final Rule asserts FDA’s legal authority to regulate LDTs and clarifies that laboratories that manufacture LDTs are subject to the same requirements as IVD manufacturers (ie, premarket review, QSRs, adverse event reporting, establishment registration and device listing, labeling standards, and investigational use requirements). Until this time, FDA has exercised general enforcement discretion over LDTs, opting not to enforce these applicable requirements. The FDA is phasing out its general enforcement discretion of LDTs in five stages over a four-year period (2024–2028). However, there is also a targeted enforcement policy in the final rule that provides limited and provisional enforcement discretion for certain types of LDTs.
In response to the final rule, laboratories are faced with how to navigate an unfamiliar FDA medical device regulatory environment, uncertainty regarding how to meet the new regulations, and tight deadlines associated with the phaseout stages. CLSI is committed to serving as a trusted resource for guidance, tools, and education to assist laboratories with preparing and meeting the new requirements.
Based on this commitment, CLSI is forming the LDT Final Rule Advisory Group to leverage the expertise of our laboratory, industry, and government subject matter experts.
Read a letter from CLSI's CEO, Dr. Barb Jones, about the recent FDA final rule on the regulation of Laboratory Developed Tests (LDTs).
FDA LDT Resources
FDA LDT Final Rule
Laboratory Developed Tests: FDA FAQs
Laboratory Developed Tests: Small Entity Compliance Guide
FDA LDT Webinars
Webinar - Final Rule: Medical Devices; Laboratory Developed Tests
Webinar – In Vitro Diagnostic Product (IVD): Classification