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.
From Our CEO
Read a letter from CLSI's CEO, Dr. Barb Jones, about the recent FDA final rule on the regulation of Laboratory Developed Tests (LDTs).
On-Demand & Upcoming Webinars | Register today for these upcoming webinars
CLSI LDT Webinar
LDT Foundations Webinar Series: Navigating Design Controls for LDTs
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 On-Demand 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
CLSI On-Demand LDT Webinar 1
LDT Foundations: An Overview of FDA's Final Rule on LDTs
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, which 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, to
LDT Related Guidelines | Find all CLSI resources related to LDT
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Product Code
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Short Title
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Publication Date
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FDA Recognition Date
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|---|---|---|---|
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EP05-A3
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Evaluation of Precision
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2014-10-01
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2015-08-14
|
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EP06-Ed2
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Evaluation of Linearity
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2020-11-24
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2021-06-07
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EP06-Ed2-EG
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Developer Validation of Linearity Establishment Guide
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2024-09-05
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|
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EP07-Ed3
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Interference Testing
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2018-04-30
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2018-09-17
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EP09-Ed3c
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Measurement Procedure Comparison
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2018-06-20
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2020-07-06
|
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EP12-Ed3
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Qualitative Test Performance
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2023-03-07
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2023-05-29
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|
EP14-Ed4
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Commutability of Processed Samples
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2022-07-14
|
|
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EP17-A2
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Evaluation of Detection Capability
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2012-06-18
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2013-01-15
|
|
EP18-A2
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Risk Management Techniques
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2009-11-30
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2010-10-04
|
|
EP18-Ed2-EP23-Ed2-WS
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Laboratory Quality Control Based on Risk Management; Worksheet Template
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2024-06-27
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|
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EP19-Ed3
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Using CLSI EP Documents
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2022-10-10
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|
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EP21-Ed2
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Total Analytical Error
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2016-07-01
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2016-12-23
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|
EP23-Ed2
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Laboratory QC Based on Risk Management
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2023-08-15
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|
|
EP23-Ed2-QG
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EP23 Quick Reference Guide
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2024-06-27
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|
|
EP23-Ed2-WB
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Laboratory Quality Control Based on Risk Management; Workbook
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2024-06-27
|
|
|
EP24-A2
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Diagnostic Accuracy Using ROC Curves
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2011-11-30
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2013-08-06
|
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EP25-Ed2
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Reagent Stability
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2023-04-26
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2023-12-18
|
|
EP27-Ed2
|
Constructing Error Grids
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2022-06-14
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2022-12-19
|
|
EP28-A3c
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Reference Intervals
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2010-10-01
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2014-01-30
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|
EP30-Ed2
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Commutable Reference Material
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2024-08-01
|
|
|
EP34-Ed1
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Dilution and Spiking for Extended Measuring Interval
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2018-08-13
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2019-07-15
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EP35-Ed1
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Equivalency of Specimen Types
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2019-12-19
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2020-07-06
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EP37-Ed2
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Interference Testing Tables
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2024-10-15
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|
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EP39-Ed1
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Surrogate Samples
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2021-11-11
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2021-12-20
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EPLDT-QG-Ed1
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Validating Performance Claims for Laboratory-Developed Tests
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2024-07-01
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|
|
MN v.2
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Unchanged Test Methods Workbook
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2024-07-17
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|
|
BPI Toolkit
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BPI Toolkit
|
2023-06-08
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|
|
M47-Ed2
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Blood Cultures
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2022-04-22
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|
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M58-Ed1
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MALDI-TOF MS
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2017-04-26
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2017-08-21
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|
MM01-Ed4
|
Molecular Genetics/Specimen ID
|
2023-06-26
|
|
|
MM06-A2
|
Quantitative Molecular InfDis
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2010-11-30
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2013-01-15
|
|
MM09-Ed3
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DNA Sequencing
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2023-04-07
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|
|
MM17-Ed2
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Molecular Multiplex Validation
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2018-05-31
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2019-07-15
|
|
MM21-Ed1
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Genetic/Oncology Microarrays
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2015-08-28
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2016-06-27
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MM22-Ed2
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Infectious Disease Microarrays
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2024-01-24
|
|
|
MM24-Ed1
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Genotyping of Infectious Organisms
|
2021-09-30
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2024-05-29
|
|
QMS01-Ed5
|
Quality Management System
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2019-06-19
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2019-12-23
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|
QMS02-Ed7
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Laboratory Documents
|
2024-03-12
|
|
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QMS05-Ed3
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Referral Laboratories
|
2020-06-02
|
|
|
QMS06-A3
|
Continual Improvement
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2011-06-30
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2014-01-30
|
|
QMS11-Ed2
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Nonconforming Events
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2015-08-25
|
|
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QMS14-Ed2
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Leadership/Management Roles and Responsibilities
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2024-10-18
|
|
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QMS18-Ed2
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Process Management
|
2023-05-31
|
|
|
QMS21-Ed1
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Purchasing and Inventory
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2016-11-01
|
|
|
QMS22-Ed1
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Laboratory Information Management
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2018-08-30
|
|
|
QMS25-Ed1
|
Quality Manual
|
2017-01-23
|
|
|
QMS26-Ed1
|
Managing Laboratory Records
|
2021-04-14
|
|
|
QSRLDT-Ed2
|
Laboratory-Developed Tests
|
2024-09-16
|
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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!
Prepare Your Lab With These CLSI Resources
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Become a member to have access to these resources and more!
Add LDT and EP to Your CLSI Areas of Interest
Crosswalk of Documents Referenced Within FDA Accreditation Checklists
NEW! Review our LDT Fact Sheet
View CLSI LDT Response Documents
FDA LDT Resources
FDA LDT Final Rule
Laboratory Developed Tests: FDA FAQs
