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Laboratory Developed Tests – LDT Solutions
For decades, Laboratory Developed Tests (LDTs) have been subject to little regulatory oversight compared to in vitro diagnostic tests (IVDs), allowing laboratories to develop and run these tests unencumbered by FDA regulatory requirements. As LDTs have become increasingly sophisticated and commercially widespread, the FDA has moved to regulate them, applying the same regulatory requirements to LDTs and IVDs.
The FDA’s new regulatory framework, subjecting LDTs to the same level of regulatory oversight as IVDs, will have a far-reaching impact for laboratories operating in this space. and underscores the critical need for laboratories developing and marketing LDTs to establish robust quality that ensure regulatory compliance and product quality.
As the LDT landscape continues to evolve, a trusted partner is crucial to stay ahead of regulatory challenges. ELIQUENT Life Sciences is uniquely positioned to support laboratories during this critical transformation. Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists partners with LDT companies to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape.
Specialized Services
As the industry leader in life sciences consulting, ELIQUENT collaborates with clinical laboratories preparing to comply with new regulatory requirements. Our tailored solutions are designed to meet the unique regulatory, quality, and compliance challenges faced by LDT developers. ELIQUENT’s LDT services include:
Regulatory Strategy Development
ELIQUENT works in partnership with companies to develop clear and effective strategies to achieve market authorization and regulatory compliance.
FDA Submission Support
From preparing pre-submission materials to supporting you through the full FDA review process, our team ensures that your regulatory submission is complete.
Quality Management Systems (QMS)
ELIQUENT advises laboratories on establishing and maintaining a robust quality system that meets FDA’s Quality Management System Regulation (QMSR), ensuring your laboratory is audit-ready and compliant.
FDA Inspection Readiness
ELIQUENT’s regulatory experts develop and implement custom strategies that prepare companies for FDA inspectional responsibilities, while aligning with global regulatory standards and expectations.
Consultation & Regulatory Guidance
ELIQUENT’s team provides market-leading insight that equips companies with solutions that reduce the risk of non-compliance while enhancing operational efficiency, product quality, and market access.
Regulatory Engagement
ELIQUENT experts guide companies through successful interactions with regulators by providing valuable support on regulatory communications, meetings, and correspondence with regulatory authorities.
Supplier Qualification & Management
ELIQUENT assesses and qualifies critical suppliers to ensure they meet FDA requirements for LDTs.
Labeling & Marketing Compliance
Our deep bench of former FDA officials and industry experts ensure your LDT’s labeling and marketing materials comply with FDA regulations.
Analytical & Clinical Evidence
ELIQUENT supports the generation of analytical and clinical evidence needed for regulatory submissions, including study design, data collection, and management.
Expert Training
ELIQUENT experts create training solutions that empower teams to elevate regulatory compliance, drawing from the industry’s largest portfolio of quality and regulatory training content.
Unmatched Expertise
With decades of experience, ELIQUENT brings the unmatched capabilities that companies need when navigating today’s evolving regulatory environment. Our team of professionals have directly influenced significant policy decisions and regulatory actions through their service at global regulatory authorities. The team’s combined capabilities and experience building effective and sustainable regulatory programs enables a cross-functional, full-service engagement that unlocks regulatory excellence.
Kalah Auchincloss
More than 15 years of experience on Capitol Hill, in the private sector, and at the FDA, including role as Deputy Chief of Staff.
Maura Norden
15+ years of professional experience advising leading medical device and drug companies on a broad range of FDA regulatory matters.
Kristen Grumet
25-year compliance career including nearly a decade as an FDA Field Investigator specializing in medical devices and quality systems compliance.
Kate Leith
40+ years experience in clinical lab, biologics, and medical device industries, spanning the product life cycle from R&D to customer support.
Comprehensive Capabilities
Historically, LDTs were developed and used within single laboratories, often in academic or clinical settings, for unique and specialized testing needs. The FDA exercised “enforcement discretion,” allowing laboratories to develop and commercialize LDTs without FDA regulatory burdens such as premarket review or needing to meet quality system requirements.
The growing complexity and high-risk nature of many LDTs have raised concerns about patient safety, test accuracy, and overall reliability. In response to these concerns, the FDA has chosen to regulate LDTs, subjecting them to the device regulatory framework applied to IVDs and other medical devices. Key regulatory changes include:
Regulatory Strategy Development
Targeted service offerings include:
Comprehensive regulatory strategy roadmap
Pathway identification (e.g., 510(k), PMA, or de novo)
Identification of classification and submission requirements
Tailored recommendations for expedited FDA approval, where applicable
Development of the premarket submission (e.g. 510(k), de novo, or PMA)
Facilitation of regulatory meetings with FDA before, during, and after premarket submission
QMS Development & Implementation
Targeted service offerings include:
Comprehensive QMS design, tailored for LDTs
Processes for complaint handling and adverse event reporting
Procedures for design control, risk management, document control, corrective and preventive actions (CAPA), and supplier management and others as applicable
Internal audit plans and audit preparation
Ongoing QMS maintenance and continuous improvement support
FDA Inspection Readiness
Targeted service offerings include:
Mock FDA inspections to assess readiness
Detailed inspection response plan development
Post-market reporting, adverse event monitoring, and CAPA implementation
Assistance with product recalls, as needed
FDA Inspection Readiness training and coaching
Supplier Qualification & Management
Targeted service offerings include:
Supplier audits and qualification protocols
Supplier risk assessments
Supplier agreements and quality contracts development
Ongoing supplier performance monitoring
Analytical & Clinical Evidence Development & Data Management
Targeted service offerings include:
Study protocols
Data collection and analysis support
Study reports preparation for FDA submissions
Labeling & Marketing Compliance
Targeted service offerings include:
Review and development of compliant product labeling
Assessment of the website and marketing claims to align with regulatory submissions
Support for promotional material review and labeling audits
Q-Submission Consulting and FDA Meeting Preparation
We assist in preparing Q-submission, including pre-submission (pre-sub), packages and facilitate meetings with the FDA to obtain feedback on your product, reducing the risk of rejections or delays.
Targeted services include:
Detailed Q-submission package preparation
Q-submission question formulation to optimize feedback
Full support for FDA interactions, including meeting preparation and follow-up
Regulatory Submission Preparation & Support
From initial submission through approval, we guide you in compiling all required data and documentation, ensuring a smooth FDA review process.
Targeted service offerings include:
Preparation of 510(k), PMA, or de novo submissions
Technical file and supporting documentation development (e.g., device description, labeling, performance data)
Review of predicate devices (if applicable) for 510(k) submissions
Assistance with responses to FDA requests for additional information (Additional Information (AI) requests)
ELIQUENT Insights
ELIQUENT’s premier team of regulatory experts routinely share their deep industry knowledge and hands-on experiences as industry thought leaders. Explore unique perspectives, actionable insights, and resources to drive your business forward.
FDA Regulation of LDTs
After nearly half a century of enforcement discretion, the FDA published its final rule on May 6, 2024, outlining a multi-year timeline to phase in the regulation of laboratory-developed tests (LDTs). Consequentially, laboratories that have historically offered LDTs without significant FDA oversight will begin to face FDA medical device regulatory requirements as soon as 2025.
Regulatory Resources.
Unlock ELIQUENT Excellence.
ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists partners with LDT companies to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape.
Learn more about ELIQUENT’s integrated LDT solutions and how our team of experts unlocks regulatory excellence:
Info Sheet
View or download ELIQUENT’s LDT Solutions Information Sheet.
Full-Service Support
Explore ELIQUENT’s comprehensive service offerings.