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Aerial View of Waves

The FDA on LDTs. Planning for Regulation Scenarios


Laboratory Developed Tests (LDTs) play a growing role in the transformation of public health and precision medicine. Last year, the U.S. Food and Drug Administration (FDA) announced plans to formally classify LDTs as medical devices, subjecting these tests to greater premarket review and post-market compliance. Leaders in life science innovation should prepare for government regulation scenarios by establishing effective risk mitigation strategies, and developing a competitive advantage  for complying with increased regulatory oversight while continuing to offer high-value LDTs. Critical steps include:

  • Creating a regulatory strategy for your organization.

  • Assessing your Quality Systems for document control, design control, production and process controls, and management controls 

  • Auditing your existing LDT development, validation and manufacturing against potential FDA rules and best-in-class quality management systems.

  • Establishing effective risk management processes to guide design and development, clinical performance evaluations, production, and post-market life cycle processes.  

  • Developing relationships and expertise in engaging the FDA and other National Competent Authorities.


The FDA defines LDTs as in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured and used within a single clinical laboratory that meets certain laboratory requirements (e.g., CLIA’88 Certification). LDTs often targeting needs unaddressed by mass-produced commercially available tests. LDTs cover a wide variety of use cases including the following: 

  • Pre-natal, post-partum diagnostics. Assessing fetal health during pregnancy and newborn screening through advanced genetic testing.

  • Oncology. Next generation sequencing panels for tumor profiling. Liquid biopsy tests for circulating tumor DNA. 

  • Infectious diseases. Multiplex PCR panels for pathogen identification. Tests could detect and identify multiple infectious agents in single sample.

  • Antimicrobial resistance testing. Specific antibiotics where a bacterial isolate is resistant.

  • Personalized Medicine. Pharmacogenomics testing. Analyze a patient’s genetic makeup to predict their response to certain medications.

  • Organ transplants. Monitoring immunosuppressant drug levels after organ transplantation. Matching human leukocyte antigen (HLA) profiles between donor and recipient.

  • Early disease detection. Identifying specific biomarkers for proactive and preventative treatments.

Major providers of LDTs include hospital systems, academic medical centers and specialized clinical laboratories. Grand View Research estimates the global LDT market at $10B in 2023, growing at a compound annual rate of over 6 percent through 2030. 

Growing Popularity -- and Uncertainty

During the Covid-19 pandemic, LDTs gained global visibility due to the unprecedented focus on rapid diagnostic tools for viral detection and antibody testing through the FDA’s and other jurisdictions Emergency Use Authorization programs to respond to a global pandemic. These tests also supported decentralized point-of-care during a period of travel restrictions, crowding limits and widespread concern around the containment of infectious illness. Progress in rapid antigen testing, CRISPR-based diagnostics and microfluidic devices enabled helped lower costs and greater accessibility.


Preparing for Possible Regulation

The FDA has announced a target for final rules in April of this year. Based on its data, this could impact 80,000 LTDs currently run by over 12,000 U.S. separate laboratories certified under the Clinical Laboratories Improvement Amendment 1988. The agency also anticipates the new regulatory guidance could generate over 40,000 premarket review submissions. This will be a significant change and now is the time to prepare.

Create/Update Your Regulatory Strategy:

  • Ensure there is an accountable owner for scenario planning.

  • Closely monitor the FDA's proposed rule and any future developments in LDT regulation.

  • Attend workshops and webinars hosted by the FDA and industry associations to stay updated on regulatory requirements and timelines.

  • Consider potential second-order effects from regulatory agencies outside the United States.

Conduct a Gap Analysis:

  • Consider using Quality Management Systems, e.g., ISO Standard 13485:2016 certification, strengthen your processes and demonstrate compliance.

  • Establishing effective risk management processes for design and development, analytical and clinical performance evaluations, manufacturing, and post-market activities. 

  • Assess your current LDT development, validation, and manufacturing processes against anticipated FDA requirements.

  • Analyze how your tests would be classified within the device pre-market authorization framework; e.g., 510(k), , de novo, Pre-Market Approval (PMA) 

  • Identify areas where your practices might need to be modified or updated to comply with new regulations.

Invest in data collection and documentation:

  • Implement robust systems for collecting and documenting data related to LDT development, validation, and performance.

  • Ensure proper record-keeping of design specifications, test results, manufacturing procedures, and quality control measures.

  • This documentation will be crucial for demonstrating safety and effectiveness to the FDA during the review process.

Build your Team's Expertise:

  • Train your staff on the new regulatory requirements and ensure they understand their roles and responsibilities in compliance.

  • Consider hiring individuals with regulatory expertise or partnering with consultants to guide you through the process.

  • Leverage existing partnerships and collaborations with other organizations to share resources and expertise.

Looking for a partner with expertise in LDTs, Regulatory Affairs, Data, Training and Quality Management? Contact Landrich Group for an initial assessment.

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