Webinar Recap: LDT Compliance Requirements for FDA Final Rule
Christine P. Bump shares key insights from the FDA’s August 22 webinar on LDTs compliance
Christine P. Bump, principal and founder of Penn Avenue Law & Policy, is an insightful regulatory attorney with two decades of experience developing and implementing FDA strategies for devices, diagnostics, digital health platforms, and genetic and genomic tests. She advises laboratories, large corporations, and emerging companies with an awareness and understanding of their business and strategic goals. Christine has served as regulatory counsel for a national diagnostic coalition, written several articles, and presented at numerous industry conferences. Before starting her firm, she practiced at Hyman, Phelps, & McNamara, P.C. and in the Life Sciences group at Goodwin. Christine earned a B.A. from Sweet Briar College, an M.P.H. from Emory University’s Rollins School of Public Health, and a J.D. from Emory University School of Law.
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Today's Clinical Lab
Yesterday’s FDA webinar regarding the FDA’s final rule on lab-developed tests (LDTs) provided excellent information about Stage 1 of the phaseout policy, including important definitions, procedures, and instructions for clinical laboratories to comply with reporting requirements.
The webinar slides, provided below, are a valuable resource to help labs understand the regulations and requirements for Medical Device Reports (MDRs) (21 CFR Part 803), Corrections and Removals Reporting (21 CFR Part 806), and Complaint Files (21 CFR § 820.198).
Key takeaways:
- MDRs will serve as a valuable source of information to help labs and the agency assess performance of tests and risks to public health. FDA can also track and trend issues about test types.
- Labs should set up accounts with FDA’s electronic systems to submit MDRs before needing to submit such reports. Detailed instructions are provided.
- Complaints are a subset of the Quality System (QS) requirements. Other QS requirements fall under Stage 3 of the phaseout policy, but compliance with complaint requirements are included in Stage 1 because of the relationship between complaints and MDRs.
- Amendments to the QS take effect on February 2, 2026, which falls between the May 6, 2025, Stage 1 deadline and the May 6, 2027, Stage 3 deadline. Complaint requirements should not be substantially different under the amended quality system (QMSR). However, labs will have to comply with any changes to complaint requirements under the QMSR by February 2, 2026.
- FDA developed new product codes that laboratories must use for reports about LDTs. The new codes are not based on test type but on the category of enforcement discretion afforded to the LDT. For example:
- SCE is for “currently marketed” LDTs,
- SCF is for LDTs offered to meet an unmet need within an integrated healthcare system,
- SCG is for modified versions of another manufacturer’s cleared or authorized test, and
- SCH is for LDTs approved by NY CLEP.
Seven LDT product codes are provided. Labs can choose to identify and use a test-specific product code as an additional product code with their reports.
- FDA provided case studies about LDT reportable events. One was for a complaint received by a test developer from a clinician because a patient’s negative test result did not match clinical symptoms. An MDR is required. Another case study was for a test developer’s discovery that a buffer reagent was contaminated. Corrections and removal are required.
- FDA explained differences between CLIA’s and FDA’s reporting and complaint requirements: CLIA’s requirements inform laboratories of operational issues at the laboratory level, while FDA’s requirements provide information about specific tests that can be used to investigate root causes.
The webinar slides are now available for download.
The FDA’s next LDT webinar will be on September 24, 2024, at 1:00 pm ET, and will cover labeling requirements for IVDs, including LDTs. Questions can be submitted in advance to CDRHWebinars@fda.hhs.gov
