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 |
|
2 | Beginning May 6, 2026 |
|
3 | Beginning May 6, 2027 |
|
4 | Beginning November 6, 2027 |
|
5 | Beginning May 6, 2028 |
|
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.
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.
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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