ChatFDA released
plus ChatMDR and ChatIVDR 3.2 with new training data
We’re thrilled to announce the release of ChatFDA, the latest addition to the ChatMDR ecosystem. Designed for professionals navigating FDA medical device regulations in the United States, ChatFDA focuses on the essential details of 21 CFR Part 800 and the latest FDA guidance documents. This tool streamlines your regulatory research, delivering the same trusted AI experience you’ve come to expect from ChatMDR.
Switching between ChatMDR and ChatFDA is effortless with our new integrated selector tool. Now, in a single conversation, you can compare insights from European MDR and U.S. FDA perspectives. Whether you’re asking about MDCG guidances or checking how the FDA addresses similar requirements, ChatFDA ensures seamless continuity without the need for multiple platforms.
The platform integrates seamlessly with our existing ChatMDR system, allowing professionals to:
- Compare European MDR and U.S. FDA regulatory perspectives within a single conversation
- Access detailed insights without switching between multiple platforms
- Reduce time spent searching through fragmented regulatory documentation
Existing ChatMDR subscribers will find ChatFDA automatically included in their current subscription. The tool is accessible at chatfda.us, representing our commitment to providing comprehensive, practical regulatory intelligence.
ChatMDR and ChatIVDR updated with latest guidances and amendments
Release 3.2 is the version number of the software that first introduces ChatFDA. But that is not all that is new. ChatMDR and ChatIVDR now have access to the latest guidance documents and amendments to the regulation, up to December 10, 2024. For easy reference, and as suggested by our customers, the learning cutoff date is now also shown on screen, at the bottom:
Recent additions to the documents include, for example:
- Regulation 2024/1860 on the gradual roll-out of Eudamed and the obligation to inform in case of interruption or discontinuation of supply
- MDCG 2024-14 through 16
- The Team NB position paper on AI in medical devices and its questionnaire
This means, for example, that ChatMDR and ChatIVDR now know what the new Article 10a is and how to apply it.
FDA Classification
We’re not quite done with the FDA tooling. Since device classification works a little differently compared to MDR and IVDR, we are currently testing a new revolutionary tool that has been trained on almost all of the device data in the FDA’s 510(k) database. That’s right, pretty much all of them: 87,891 devices at last count!
Watch this space for the release of FDAClassification, a tool that will not just classify the device but also find substantially equivalent devices for your 510(k) submission.
FDAClassification, January 2025.