FDA Classification and other enhancements in ChatFDA / ChatMDR 3.3
The latest release of our regulatory AI suite brings some interesting enhancements. A whole new feature aimed at devices under the 510(k) substantial equivalence schemes and functionality enhancement for all tools, whether you’re looking at Europe or the US and at medical devices or in-vitro diagnostics..
FDA Classification
Perhaps the most significant addition is the FDA Classification feature, which transforms how manufacturers identify predicate devices. For this powerful tool, we trained our AI on the contents of the entire FDA 510(k) database, containing over 80,000 devices. It can match devices based on their indications for use and modes of action. But of course you can also simply put in the names of some devices you know!
Traditional database searches often struggled with these nuanced aspects of device classification. Regulatory professionals typically had to wade through countless entries, trying to match technical characteristics and intended uses manually. This was because the view of the FDA was on the individual device records and not their types; a cardiovascular catheter could follow an ultrasound machine. The new FDA Classification feature changes this paradigm by understanding the context and meaning behind your device’s characteristics. Learn more about FDA Classification here.
Enhanced Reasoning with o3-mini Model
The integration of the o3-mini model represents a big step in the AI’s reasoning capabilities. Reasoning is now smarter, context is utilized more richly, and the answers you get are more directly actionable. It is hard to quantify how o3-mini performs compared to o1 preview, the old Diamond model. The benchmarks online are usually for coding or math, which are quite different applications than regulatory affairs!
That’s why we put the models to the test, compared to o1 preview (previous Diamond) and o1 (the final version of o1, good but quite slow). o3-mini won in 80% of cases, 20% went to o1 and o1-preview was never the best in the comparison. This advanced reasoning model is currently an exclusive for Plus and Unlimited subscription tiers.
Read more about o3-mini here and see how you can upgrade your subscription if you’re still on ChatMDR Free.
Hyperlinks: Bringing the Web Back to the Future
In a delightfully ironic twist, we’ve implemented one of the original features that defined the World Wide Web – hyperlinks – into the world’s most advanced regulatory AI. Users can now click through directly to referenced MDR Articles, MDCG guidances, and FDA 21 CFR part 800 entries. This seamless integration with source documents brings us full circle, combining the web’s foundational feature with cutting-edge AI technology to create a more efficient regulatory research experience.
Quality-of-Life Improvements
Understanding the importance of discretion in regulatory work, we’ve added a simple but useful feature that allows users to hide their chat history when taking screenshots. This ensures that sensitive information remains private while sharing specific regulatory guidance or classifications. You can see it in the image about hyperlinks: the chat history is conveniently folded.
The latest update also includes comprehensive content updates, incorporating all MDCG guidances and regulatory documents published through February 4, 2025. This ensures that users have access to the most current regulatory information for their decision-making processes.
Enjoy the new version of ChatMDR, ChatIVDR and ChatFDA!