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Lab-Developed Tests

What you need to know as a result of FDA’s Final Rule issued on April 29, 2024

Beginning on May 6, 2025, the FDA will expect compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files.

FDA logo

Key aspects of the regulation includes:

Classification

LDTs will be classified based on their risk level, with higher-risk tests subject to more stringent requirements.

Registration

Laboratories developing and performing LDTs will be required to register with the FDA.

Premarket review

Certain LDTs, particularly those deemed high-risk, will undergo premarket review to assess their safety, effectiveness, and quality.

Good Laboratory Practices (GLP)

Laboratories will be required to adhere to GLP standards to ensure the reliability and accuracy of their test results.

Quality System Requirements

Laboratories will need to implement quality systems to manage the entire LDT development and testing process.

important prepare and respond

Your current certifications, both federal and state, compliance manuals and practices will not meet the new regulations.

Are you ready for stage 1 compliance on May 6, 2025?

Important Features of the LDT Regulation

FDA is taking a staged phase out approach through a 5 stage process

The FDA also intends to exercise enforcement discretion. Categories of IVDs manufactured by a laboratory will be targeted. A partial listing has been provided by the FDA.

May 6, 2024 was the start of a new normal for laboratories.

What follows is the journey that all Laboratories will have to take.

Stage 1:

beginning on May 6, 2025

FDA will expect compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files.

Stage 2:

beginning on May 6, 2026

FDA will expect compliance with requirements not covered during other stages of the phaseout policy, including registration and listing requirements, labeling requirements, and investigational use requirements.

Stage 3:

beginning on May 6, 2027

FDA will expect compliance with QS requirements (other than requirements regarding complaint files which are already addressed in stage 1).

Stage 4:

beginning on May 6, 2027

FDA will expect compliance with QS requirements (other than requirements regarding complaint files which are already addressed in stage 1).

Stage 5:

beginning on May 6, 2028

FDA will expect compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs (that require premarket submissions), unless a premarket submission has been received by the beginning of this stage in which case FDA intends to continue to exercise enforcement discretion for the pendency of its review.

Suggested steps to comply with FDA regulations

Understand the regulation and the staged approach as these regulations are here to stay

  • We can help with targeted training and resources
  • Applying train the trainer concepts to minimize cost and accelerate adoption of the regulation is recommended

Create a plan that incorporates seasoned professionals and laboratory leads

  • Classification of our LTD’s is an important first step to understand the effort that will be needed to meet the new regulation
  • Stage 3 will require a deep understanding of the FDA’s defined Quality Management Systems requirements. This includes: design controls, purchasing controls, acceptance activities, CAPA, and records requirements
  • We can help create a plan to meet your specific laboratory needs

Potential FDA inquiries will require knowledgeable personnel with extensive experience to avoid FDA actions. MDI has extensive experience with the FDA.

 

Create an auditing process to confirm compliance to stay ahead of any potential FDA actions. will be your long-term life line for all your compliance needs.

Helpful Links

Gather information on the LDT regulation through FDA’s website

https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests

 

Frequently asked questions from FDA

https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-faqs

Contact mdi Consultants now to stay in compliance