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LDT Management
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A ONE-STOP
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.

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  • Comply with new regulations

  • Pre-built LDT templates

  • Easy to Customize

  • Targeted solutions for laboratories

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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 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 by Vastian 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 Patient Complaints
Available Now

  • Use IQE to Collect, Review, Manage, and Track/Trend Non-Conforming Events

  • Use IQE to Collect, Review, Manage, and Track/Trend Patient Complaints

  • Use IQE to Document and Submit Corrections and Removals

  • Maximize time with IQE’s easy-to-use, built-in triggers to submit to FDA when appropriate.

  • Access our LDT Stage 1 Educational Training Course for laboratorians

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

  • Use our LDT Solution to Generate, Approve, and Validate your Regulatory Labels to comply with FDA’s Labeling Requirements

  • Use our LDT Solution to Manage IDEs, Informed Consent, IRB Approval Process, and more to comply with FDA’s Investigational Use Requirements

  • Increase efficiency with our LDT solution’s e-submitter integration to seamlessly send your forms and data to FDA for review.

  • Access our 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)

  • Use our LDT Solution to Create, Review, Approve and Monitor all Processes, From Design Controls to Purchasing Controls to Acceptance Activities and more

  • Access our 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

  • Access LDT Stage 4 & 5 Educational Training Courses for labroatorians

Stay Ahead of FDA’s LDT Regulations with MediaLab by vastian

By centralizing and optimizing critical quality system processes, MediaLab by Vastian 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 by Vastian 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: Our built-in apps and forms support risk management activities aligned with FDA expectations, identifying potential compliance issues before they become problematic.

Quality management & validation

MediaLab by Vastian 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 & reporting

MediaLab by Vastian allows laboratories to manage and report adverse events, complaints, and corrective actions to maintain ongoing compliance with FDA regulations.

  • Optimized Adverse Event Handling: We support 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.

Navigate Compliance with Confidence

Your Partner for Navigating the New Regulatory Landscape

Real-time compliance dashboards

We offer 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 & 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

We provide continuous education and updates, informing lab teams on evolving FDA LDT regulations.

Unparalleled security

We ensure secure data storage, protecting your lab’s sensitive information with SOC 2, Type II compliance and FedRAMP authorization.

Seamless Integration: LDT Compliance Meets Document Control and IQE

Elevate your compliance strategy by harnessing the power of integrated Document Control and IQE within the MediaLab by Vastian platform.

Document Control

Automatically link LDT compliance records with Document Control, ensuring all regulatory documents are securely stored and easily accessible.

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Intelligent Quality Engine (IQE)

Facilitate real-time data exchange between the LDT app and IQE’s complaint and event management modules, enabling prompt corrective actions and comprehensive reporting.

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A Deeper Look

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