New FDA Dataset Marks a Transformative Leap for Chemical Characterization

We're thrilled to announce a significant development from the FDA’s Center for Devices and Radiological Health (CDRH) that introduces a new regulatory science tool for chemical characterization. This groundbreaking tool is a huge step moving toward improved chemical characterization methods that fits well with Jordi Labs current procedures.  

A Step Towards Enhanced Safety and Efficacy in Medical Devices

The FDA's latest initiative marks a crucial milestone for the chemical characterization field. The launch of the Chemicals List for Analytical Performance (CLAP) tool by the CDRH is a significant step towards enhancing the safety and efficacy of medical devices. This tool will provide labs with a benchmark for assessing analytical method adequacy through an initial set of chemicals and their associated relative response factors (RRF), which have been selected based on a broad spectrum of physicochemical properties.

Jordi Labs by RQM+ at the Forefront

It’s a proud moment for us at Jordi Labs, as our longstanding commitment and advocacy for rigorous chemical characterization approaches have helped to lay the groundwork for this initiative. Our team’s proactive approach in establishing a broadly constituted relative response factor database and deriving appropriate uncertainty factors has been industry-leading, and the publication of FDA’s CLAP tool represents a paradigm shift towards alignment with this approach.

Industry Implications

Specific guidance regarding analytical method adequacy for device chemical characterization studies is currently lacking in the ISO 10993-18:2020 standard. Furthermore, the accepted practices for characterizing the uncertainty of analytical methods and deriving uncertainty factors for analytical evaluation threshold (AET) application are based either on arbitrary values or on statistical calculations which are unsuitable for the methods commonly used for this testing.

The FDA's endorsement of approaches that align with our practices signifies a pivotal change in the industry. It encourages other labs and organizations to adopt more robust testing approaches, ensuring better patient outcomes. As the FDA continues to expand this database to include additional gas chromatography data and additional methods, such as liquid chromatography, Jordi Labs remains committed to transparency with the FDA regarding our approaches.

Our Continuous Advocacy for Excellence

Several years ago, Jordi Labs recognized the need for more comprehensive standards in dealing with uncertainty in analytical instrument responses. Unlike many others content with the status quo, our lab embarked on a rigorous effort to challenge and change the existing norms.

Our work in this area has not only been about advancing our capabilities but also about setting new benchmarks for the industry. The publication of our findings and the implementation of these standards in our lab back in 2020 were just the beginning.

Together, let’s continue to set new standards and ensure that our advancements in chemical characterization not only meet but exceed regulatory expectations, paving the way for safer medical devices around the globe. Contact our team today to learn more about how Jordi Labs by RQM+ can support your full lifecycle materials science and chemical characterization needs.