Looking Towards 2025: The FDA, LDTs, and the Migration from CSV to CSA
Home > About Us > News & Events > Looking Towards 2025: The FDA, LDTs, and the Migration from CSV to CSA
Looking Towards 2025: The FDA, LDTs, and the Migration from CSV to CSA
December 23, 2024
Regardless of your personal politics, new administrations bring an opportunity for change. For LEAP and our clients and partners, we’re watching two areas of government regulation that can have a major impact on what we do.
First, the FDA Final Rule on Laboratory Developed Tests. Specifically, the FDA finalized a rule that subjects laboratory developed testing services — often referred to as “LDTs” — to new federal regulation by FDA as medical devices. Organizations that collectively represent the nation’s leading clinical laboratories, laboratory directors, analysts, pathologists, and other physicians and laboratory professionals have written a letter to the incoming administration transition team requesting that they withdraw this misguided and unlawful rule when President Trump takes office.
Leap Consulting Group agrees with the authors of the letter: the American Clinical Laboratory Association (ACLA), the American Association of Bioanalysts and its division the National Independent Laboratory Association, the American Society for Clinical Pathology (ASCP), the American Society for Microbiology, the Association for Diagnostics & Laboratory Medicine, and the Infectious Diseases Society of America.
The second regulation issue close to our hearts concerns the migration from Computer Systems Validation to a CSA model for use in regulated pharmaceutical laboratories. The FDA draft guidance “Computer Software Assurance for Production and Quality System Software.25” was published in September 2022. Given that they started looking at this issue back in 2011, and promised draft guidance in 2018, we feel that they’ve been moving too slowly throughout this process. In fact, Boston Scientific is actively using CSA and advocating heavily for others to do the same. At a recent conference, we heard Johnson & Johnson, Alexion Pharmaceuticals, Inc., and GSK say that they are all either already using CSA or in the process of transitioning.
Here at LEAP we’re excited about the transition. We know it’s coming, and we have hope that it will create the kind of process simplifications and paperwork reduction around the process of software validation, especially commercially available software. This article in Technology Networks by analytical chemist Bob McDowall, PhD looks at the situation in great detail. It’s worth a read, although we don’t necessarily agree with his conclusion that CSA is more a confidence trick than a perfect solution.
If you’d like to discuss the implications for your organization of either migrating from CSV to CSA or the FDA Final Rule on Laboratory Developed Tests, contact us and let’s talk.