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Proposed FDA Regulations on LDT's: What You Should Know

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Proposed FDA Regulations on LDT's: What You Should Know

Learn more about how the FDA's recent rule on Laboratory Developed Tests (LDTs) could impact the in vitro diagnostic industry (IVD) in our guide below.

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Stay prepared by understanding the latest proposed U.S Food and Drug Administration’s (FDA) regulations on Laboratory Developed Tests (LDTs). An LDT is a test developed and manufactured inside a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory for use only within that laboratory. Our guide provides an overview of the impending changes, timelines, and what it means for LDT developers. Explore the support available to navigate this new era of regulatory oversight.

Key Highlights

  • An Overview of the Proposed FDA Regulations on LDTs 
  • Why the Shift in FDA Regulation?
  • Exceptions to FDA Oversight
  • Phased Enforcement of FDA Oversight
  • How to Prepare

Benefits of Partnering with the IVD Solutions Team at TE

  • Global Full-service Clinical Research Organization (CRO) Capabilities, Specializing in In Vitro Diagnostics (IVD)
  • Setting the Stage for a Successful Regulation Submission
  • Shortening the Path to Commercialization
  • 200+ Clinical Trail Sites
  • 45 Regulatory Approval Including, 510(k), CLIA Waiver, EUA, DeNovo and CE Mark

Stay informed about the impending changes in FDA regulation for LDTs. Don’t wait - get ahead of the curve with the support of experienced professionals like the IVD Solutions team at TE Connectivity (TE), who can help you embrace these changes with confidence. 


Engage with TE's IVD Solutions team for a Free CRO Consultation.

 

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Frequently Asked Questions

1

What are the changes proposed by the FDA’s regulations on LDTs?

This proposed rule change will end the FDAs enforcement discretion on LDTs and lay out the rules and timeline for LDTs to comply with FDA in-vitro diagnostic (IVD) requirements.

2

Will all LDTs be open to these proposed regulations?

There are three exception categories to these changes. Download the guide to learn more about these exceptions.

3

What is the timeline for implementing these new changes?

There are five stages to these proposed changes spanning from the present to 2028.

4

How should laboratories prepare for these changes?

Having a general understating of your LDT classification and aligning that to the FDAs requirements is a proactive start in preparing for these changes. Seeking an experienced CRO’s guidance such as our IVD Solutions team at TE will further your confidence in these proposed changes.

5

How will the new regulations impact the development timeline of LDTs?

These changes may extend timelines depending on what category your LDT falls into. Planning for these changes and teaming with an experienced CRO may help in reducing delays to your LDTs timeline.