In its final rule on laboratory-developed tests (LDTs), the FDA acknowledged that "some laboratories may lack familiarity, experience, or existing infrastructure for complying with FDA requirements" and indicated the agency would publish a "small entity compliance guidance" to assist small businesses. This blog will summarize key requirements to consider and how OneGlobal Trinity M Consulting can support with your transition to new rule.
Key Regulatory Requirements
Complaint Handling: Laboratories must comply with Medical Device Reporting (21 C.F.R. § 803), Reporting of Corrections and Removals (21 C.F.R. § 806), and Complaint Files (21 C.F.R. § 820.198) by May 6, 2025. FDA’s regulations require written procedures for complaint handling, detailed records of complaints, and maintaining complaint files for at least two years from the date of release for commercial distribution .
Medical Device Reporting (MDR): Laboratories must report deaths, serious injuries, and certain device malfunctions. They must develop MDR procedures, train employees, and submit reports in electronic format .
Corrections and Removals: Laboratories must report and maintain records of corrections and removals within 10 working days if they reduce a health risk or remedy a violation of the act .
Labeling Requirements: FDA regulations, including UDI, will require compliance by May 6, 2026. Laboratories must identify labeling requirements relevant to LDTs and ensure compliance with FDA standards .
Implementation Challenges
Laboratories may find it challenging to align their existing complaint handling procedures with FDA’s detailed requirements. The term "labeling" and "commercial distribution" need clear definitions in the context of LDTs. Moreover, laboratories must navigate the complexities of MDR reporting, corrections, and removals without established practices in place.
Partnering with OneGlobal Trinity M Consulting
OneGlobal Trinity M Consulting is uniquely positioned to assist laboratories in navigating the transition to the FDA’s final rule on laboratory-developed tests (LDTs). Our team of seasoned experts, with extensive backgrounds in regulatory affairs, quality management, and clinical operations, provides tailored support to ensure compliance with new FDA requirements. Our consultants work closely with your laboratory to interpret and apply FDA regulations effectively, minimizing disruptions and ensuring a smooth transition. We offer comprehensive services, including the development and implementation of complaint handling procedures, medical device reporting (MDR) processes, and records management for corrections and removals.
Deep Industry Experience: Our experts understand the intricacies of regulatory compliance and can guide you through the FDA’s requirements efficiently.
Consulting Expertise: Our team’s extensive experience ensures that we can provide the strategic advice and practical solutions you need.
Custom Services & Solutions: We tailor our services to meet your unique needs, ensuring effective compliance and successful project outcomes.
Conclusion
By leveraging our deep industry knowledge and practical expertise, OneGlobal Trinity M Consulting ensures your laboratory is fully prepared to meet the FDA's stringent standards and maintain operational excellence. Contact us today to learn more.
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