Empowering Your Team to Navigate the Final LDT Rule

FDA’s Final LDT Rule – Obstacle or Opportunity?

The FDA’s final rule on Lab Developed Tests (LDTs) presents significant challenges and opportunities. For clinical laboratories, these new regulations can be a daunting addition to their already demanding responsibilities.

Tailored Support Solutions for Clinical Laboratories

LDT to IVD Training

Training sessions crafted to equip you and your team with the essential knowledge and skills needed to comply with the new LDT rule

Regulatory & Quality Gap Assessments

Identify the gaps in your existing regulatory and quality systems with a comprehensive regulatory and quality assessment

Strategic Support

Comprehensive regulatory, quality, and clinical strategies are crucial when developing your test or transitioning it to an IVD

Full LDT to IVD Execution

Get end-to-end strategic, clinical, and execution support to convert your LDTs to FDA-cleared or FDA-approved IVDs

Bridging the gaps, scaling quickly

MDC Associates is here to bridge the gap between understanding the requirements and processes, teaching and guiding, and executing the complex changes. We can help your team quickly scale up and successfully navigate the new LDT regulatory landscape.

LDT to IVD Training

Training session modules include:

  • LDT Final Rule Overview
  • Regulatory 101
  • Quality System Requirements (QSR/QMSR)
  • Product Development, Design Controls, and Risk Management
  • Clinical Studies

Each session lasts approximately 60-90 minutes and includes interactive Q&A time with our seasoned experts who have been closely following these regulations.

  • Expert-led Sessions: Interactive training with live Q&A
  • Comprehensive Modules: Detailed coverage of regulatory and quality requirements
  • Flexible Scheduling: Convenient training sessions designed to fit your team’s schedule

Regulatory & Quality Gap Assessments

Actionable assessments of the current state.

You’ll receive comprehensive assessments that identify the gaps in compliance of your organization’s existing regulatory and quality systems.

You’ll understand the necessary changes to achieve compliance and receive support throughout your implementation efforts, ensuring your lab fully meets the new FDA requirements.

  • Detailed Evaluations: Comprehensive analysis and assessment of current systems and processes
  • Customized Recommendations: Clear, tailored action plans to address identified gaps
  • Implementation Support: Guidance and expert support through the implementation process

Strategic Support (RA / QA & Clinical)

Developing comprehensive regulatory, quality and clinical strategies is crucial.

Our experts will collaborate with you to create a tailored plan that addresses your specific needs, guides the conversion of each specific LDT to an IVD, and helps you navigate the new regulatory landscape with confidence.

  • Tailored Strategies: Customized plans to successfully meet your regulatory, quality, and clinical goals
  • Risk Management: Proactive identification and mitigation of potential regulatory risks.
  • Ongoing Support: Continuous guidance throughout the regulatory process.

Full LDT to IVD Execution

Get end-to-end development and execution support to convert your LDTs to FDA-cleared or FDA-approved IVDs.

Our team will guide you through each step, providing the expertise and support needed to ensure a smooth and compliant transition.

The Full LDT to IVD Execution program is a tailored option that encompasses all facets of the regulatory, quality, clinical study, and data management support.

  • End-to-End Management: Comprehensive support from initial assessment to final clearance or approval
  • Expert Guidance and Execution: Dedicated team of experts to guide you and help execute each step
  • Compliance Assurance: Ensuring all requirements are met throughout the process

Why MDC Associates?

MDC Associates is your trusted partner for CRO services, data management, regulatory affairs, and quality systems with extensive experience established over 35 years.

We’re committed to empowering clinical laboratory teams to quickly and effectively scale up and achieve compliance with the new LDT rule.

  • We develop regulatory strategies with our customers to achieve their objectives.
  • We offer full services, tailored to your specific needs.
  • We can interact with FDA on your behalf, guiding you through the process.
  • We can help you define and build the FDA mandated systems and processes that you need.
  • Our goal is to help your team build an internal skillset that won’t require ongoing outside support.

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