MediaLab LDT Solution

The Most Comprehensive and Targeted LDT Solution

Leverage the expertise of the #1 lab compliance software company in the country that is developing a customized, comprehensive LDT solution to meet your needs.
  • Comply with New Regulations
  • Pre-built LDT Templates
  • Easy to Customize
  • Targeted Solutions for Laboratories

Navigate Compliance with Confidence: Your Partner for Navigating the New Regulatory Landscape

  • Real-time Compliance Dashboards: MediaLab offers real-time compliance dashboards, providing instant visibility into the status of LDT regulatory requirements.
  • Full Audit Trails: We provide comprehensive audit trails, tracking every change and decision for full FDA compliance visibility.
  • Robust and Customized Reporting: Customizable reporting tools simplify the generation of detailed compliance reports and data.
  • Centralized Management: We enable centralized management of quality processes, ensuring consistent FDA compliance across all LDTs.
  • Educational Updates: MediaLab provides continuous education and updates, informing lab teams on evolving FDA LDT regulations.
  • Unparalleled Security: MediaLab ensures secure data storage, protecting your lab’s sensitive information with SOC 2, Type II compliance, and FedRAMP certification.

What is happening to LDTs?

Starting May 6, 2025, the FDA is changing the definition of regulation 21 CFR 809.3 on IVD products by adding 10 words: in vitro diagnostic products include when the manufacturer of these products is a laboratory. This will impact roughly 12,000 clinical labs that registered to develop and deploy LDTs in 2020. Now, laboratories must follow FDA regulations in addition to CLIA/CMS and other accrediting bodies, such as CAP. This constitutes a heavy lift (and expense) for most laboratories that are not familiar with or accustomed to FDA oversight. Over the next 4-years, the FDA will roll out a 5-stage stage-out policy for enforcement of LDTs under medical device law. MediaLab has plans to meet you at each stage and support you through each one during this transition.

MediaLab’s 5-Stage Plan for LDTs

MediaLab is the only software company 100% committed to developing a solution that is tailored exclusively to LDTs and the demands it brings. With over 80% of our 5,000 labs impacted by this new change, MediaLab has a deep passion and commitment to be sure each lab has what they need to meet this challenge.
Our solution will be rolled out in stages to align with the FDA’s plan with each MediaLab stage launching well in advance of enforcement, providing adequate time to be ready.

Stage 1 Support

Non-Conforming Events and Complaints
Available Now
  • Use our IQE application to:
    • Collect, Review, Manage, and Track/Trend Non-Conforming Events
    • Collect, Review, Manage, and Track/Trend Complaints
    • Document and Submit Corrections and Removals
  • IQE includes easy-to-use, built-in triggers to submit to FDA when appropriate.
  • LDT Stage 1 Educational Training Course for laboratorians.
This stage is provided at no additional cost to any client who currently has IQE with MediaLab. Learn more about IQE's benefits and features here.

Stage 2 Support

FDA Registrations and Listing, Labeling, and Investigational Use Requirements
Begins January 1, 2025
  • Use our LDT solution to:
    • Submit, Update, and Track FDA Registration and Listing Requirements Data for your Laboratory
    • Generate, Approve, and Validate your Regulatory Labels to comply with FDA’s Labeling Requirements
    • Manage IDEs, Informed Consent, IRB Approval Process, and more to comply with FDA’s Investigational Use Requirements
  • Our LDT solution includes e-submitter integration to seamlessly send your forms and data to FDA for review.
  • LDT Stage 2 Educational Training Course for laboratorians.

Stage 3 Support

FDA QMSR Requirements
Begins December 1, 2025
  • Use our LDT solution to:
    • Manage Quality System Regulation Requirements, including the updated FDA QMSR requirements (harmonization with ISO 13485).
    • Create, Review, Approve and Monitor all Processes, From Design Controls to Purchasing Controls to Acceptance Activities and more.
  • LDT Stage 3 Educational Training Course for laboratorians.

Stage 4 & 5 Support

FDA Pre-Market Review Requirements for High, Moderate, and Low-Risk IVDs
Begins June 1, 2026
  • Use our LDT solution to:
    • Collect, Prepare, Approve and Submit required PMA documentation to create a complete PMA application.
    • Use eSubmitter PMA data fields as required by the FDA.
  • LDT Stage 4 & 5 Educational Training Course for laboratorians.

Stay Ahead of FDA’s LDT Regulations with MediaLab

By centralizing and optimizing critical quality system processes, MediaLab enables laboratories performing LDTs to navigate the complex FDA regulatory landscape with confidence. True to our approach, MediaLab designs our solutions to support regulatory adherence, and improve quality processes, positioning your laboratory for sustained success, audit readiness, and poised to show your higher standards.

Proactive Regulatory Alignment

Now that LDTs are under more rigorous oversight, MediaLab helps laboratories comply with existing and newly updated regulatory frameworks.
  • Streamlined Premarket Submission: Simplify the premarket review process by generating and compiling all necessary documentation for FDA submission.
  • Templated Forms and Processes: Use our pre-configured forms and processes that align with FDA regulations to ensure all critical compliance tasks are completed systematically.
  • Risk Management Activities: MediaLab’s built-in apps and forms support risk management activities aligned with FDA expectations, identifying potential compliance issues before they become problematic.

Quality Management and Validation

MediaLab assists laboratories by providing robust quality management systems that meet FDA standards.
  • Integrated Quality Management System (QMS): Manage all aspects of your laboratory’s QMS in one platform, from complaint files to design controls, and more.
  • Comprehensive Document Control: Maintain full control over all documentation related to LDT development and validation, with version control and secure storage to ensure compliance with FDA’s QMSR.
  • Cross-Functional Collaboration Tools: Facilitate collaboration across different departments involved in the LDT process with integrated communication and task management tools.

Post-Market Surveillance and Reporting

MediaLab allows laboratories to manage and report adverse events, complaints, and corrective actions to maintain ongoing compliance with FDA regulations.
  • Optimized Adverse Event Handling: MediaLab supports the reporting of adverse events to the FDA, while maintaining compliance with Medical Device Reporting (MDR) requirements.
  • Complaint and CAPA Management: Efficiently manage complaints and implement CAPAs with integrated workflows, ensuring every issue is tracked, resolved, and reported in compliance with FDA regulations.
  • Customizable Compliance Alerts: Receive real-time alerts customized to your laboratory's specific needs, ensuring you’re notified of deviations or potential compliance issues.