FDA Classification
FDA Classification is a tool that augments ChatFDA with one very specific function: finding the device class for a medical device and possible equivalent devices in the FDA’s 510(k) database.
How to use
You find FDA Classification in the dropdown menu, right under ChatFDA.
The input to FDA Classification is as much information as possible about your device. The more you put in, the bigger the chance that an equivalent device is found. For example:
- Intended Use
- Indications for Use
- Mode of action
- Peripherals, like remote controls, wireless accessories
- The (intended) name of the device, if it’s descriptive
- The clinical area (e.g. angioplasty, brachytherapy)
Most of the time, you can probably copy/paste this information simply from your technical files.
Examples
That one was pretty straightforward. A more difficult one:
Workflow differences with ChatFDA
There are two key differences when working with FDA Classification:
- The classification tool has its own history. Because the conversational history is used very differently in the normal chatbots, our designers thought it better to separate the chats. You can also have a quicker overview this way for all your FDA classification requests, which are probably less frequent in your work than the day-to-day AI use. ChatMDR, ChatIVDR and ChatFDA chats are still shared.
- There is no model selector (Fast, Smart, Diamond) in FDA Classification. There is intelligence in the model where it chooses the best alternative based on the question asked. In practice, this is a combination of Fast and Smart.