“We know how to do it right the first time, including the right level of detail and effort based on your business goals and the risk of your particular tests or devices.”
–Chad Gibson, Managing Partner
CMD MedTech The FDA is ending its enforcement discretion policy for Laboratory Developed Tests (LDTs), requiring labs and hospital systems to comply with medical device regulations. These changes affect hospital labs, testing facilities, and healthcare systems that have historically operated with minimal FDA oversight, particularly impacting genetic testing, blood tests, and other diagnostic procedures. With decades of medical device experience, CMD MedTech is a laboratory developed test consultant helping organizations develop practical, right-sized solutions that ensure compliance while maintaining efficient operations.
Why Choose CMD MedTech for LDT Regulatory Compliance
- Extensive experience helping medical device companies develop processes and documentation required for FDA compliance
- Ability to implement quality systems efficiently with minimal impact on laboratory operations
- Deep understanding of both FDA requirements as they apply to hospital laboratory operations
- Experience coordinating compliance across multiple laboratory facilities
- Expertise in managing documentation and validation requirements in accordance with 21 CFR Part 11
- We offer our Astro electronic document tool for maintaining electronic records
- Quality systems that improve operations and enhance patient safety
HOW WE PRICE OUR LDT SERVICES
We understand that every laboratory and hospital system has unique needs and organizational structures. Our pricing is customized based on your specific requirements, whether you need support for a single laboratory or a multi-lab hospital system. We offer both time-and-materials and fixed-price engagements, allowing flexibility to match your project scope and budget. Contact us to discuss your laboratory’s specific needs and receive a detailed pricing proposal.
5-Step Process for Getting Started With an LDT Quality Management System
5-Step Process for Success With LDT Support
Additional Services We Provide
Virtual Quality Support Services
We help with training, document completion, and quality system facilitation to maintain ongoing laboratory developed test compliance.
Quality System Maintenance
We provide support for management reviews, internal audits, and continuous system improvement.
Staff Training and Development
We help laboratory staff understand and implement new regulatory requirements efficiently.
Electronic Document Management
Through our Astro platform, we provide FDA 21 CFR Part 11-compliant electronic records and electronic signature systems.
New Test Development Support
We assist with FDA submissions and documentation requirements when introducing new tests.
FREQUENTLY ASKED QUESTIONS
While some changes will be necessary, CMD MedTech structures implementation to minimize impact on day-to-day operations as an LDT consultant. We help you find the right balance between compliance and efficiency, focusing on practical solutions that work within existing workflows.
You should begin implementation now. With deadlines approaching in early May 2025, waiting could put you at risk of non-compliance. While there may be some industry pushback, it’s better to be prepared than to risk non-compliance.
Yes, many of the practices used to develop an LDT quality system are beneficial for your laboratory operations regardless of FDA requirements. Think of them as a way to make your lab even better–good documentation practices, managing test changes, and having structured processes contribute to better patient safety and reduced liability. As testing becomes more complex, having these systems in place helps ensure consistent, reliable results.
We work with hospital administration to determine the most effective way to implement hospital lab FDA compliance across multiple labs. Our team helps establish reporting structures and coordinates between different departments to ensure consistent implementation.
While the FDA won’t immediately inspect every lab, non-compliance could lead to serious consequences including potential lab shutdown in cases of problems or adverse events. FDA can now enforce requirements and may make examples of egregious violations.