Is Your Organization Ready for the FDA’s New LDT Compliance Requirements?

What You Need to Know About the FDA’s New LDT Regulation

The FDA is phasing out their general enforcement discretion approach for LDTs in favor of a medical device approach.

But what does that mean for manufacturers and laboratories offering LDTs to their customers? 

It means that over the next four years, in vitro diagnostics (IVDs) offered as LDTs will need to comply with applicable medical device reporting requirements, which are very different from traditional CLIA and CAP requirements followed by most clinical laboratories. 

Will your organization be ready? More importantly, do you know what you need to do to meet the first LDT deadline in May 2025? That’s when FDA expects labs performing LDTs to comply with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files.

Stage Date Requirement goes into effect General FDA Expectations for the LDT manufacturer
1 Beginning May 6, 2025
  1. Medical Device Reporting
  2. Correction and Removal reporting
  3. Quality System requirements regarding Complaint Files
2 Beginning May 6, 2026
  1. Registration and Listing requirements
  2. Labeling requirements
  3. Investigational Use requirements
  4. Requirements not specifically listed in other stages
3 Beginning May 6, 2027
  1. Compliance with the remaining QS requirements (Other than complaints addressed in Stage 1)
4 Beginning November 6, 2027
  1. Compliance with pre-market review for high-risk IVDs offered as LDTs (Class III IVDs or subject to licensure under sec. 351 of the PHSA)
5 Beginning May 6, 2028
  1. Compliance with pre-market review for moderate-risk and low-risk IVDs offered as LDTs

The transition will occur in a phased approach, with the first deadline occurring on May 6, 2025, when FDA will expect labs performing LDTs to comply with correction and removal reporting requirements, and quality system requirements regarding complaint files. 

What Does It All Mean?

Here’s a brief breakdown of the Phase I requirements (due by May 6, 2025):

Medical device reporting (MDR) is the process for submitting certain reports to the FDA regarding adverse events and product issues related to the laboratory developed test.

Organizations must also report to the FDA any correction or removal of an LDT if the action was taken to reduce a health risk or to address a violation of the law that may present such a risk.

Lastly, organizations must implement a corrective and preventive action (CAPA) plan as part of their quality system, to ensure that they are tracking complaint and/or problem trends with their LDTs.

This is new regulatory language for clinical laboratories used to operating under a specific set of requirements, and it’s causing quite a stir. Many organizations have already chosen to remove their LDTs from the market, rather than deal with new and complex requirements.

Don’t risk losing your position in the LDT market.
Reliant Life Sciences can help.

For years, our medical device consultants have worked with medical device manufacturers to craft complete regulatory submissions and implement compliant quality, labeling, documentation and reporting systems. They have extensive experience with FDA medical device regulation and can help walk you through what you need to do to keep your LDTs compliant – and on the market. 

Give Reliant a call today to learn more about how we can help you successfully navigate the transition to new LDT regulation.  

Contact Us

Email us at [email protected] or call (603) 471-4100 to discuss how Reliant Life Sciences can help you overcome your toughest remediation challenges

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