The purpose of this application is to make the FDA's public databases easier to navigate. We hope it will be useful to regulatory consultants, engineers, investors, and buyers in the medical device industry. In particular, it should help you classify a medical device idea or identify a predicate device.
The main pane combines information from various FDA databases into a browsable tree. The top nodes are classification panels, their children are CFR sub-parts, their children are product codes, and their children are premarket submissions (510(k)s, de Novos, or PMAs). Click a node to view details about it, including a link back to where we gathered the information in the FDA's databases.
If you find an error or want to suggest an improvement, please open an issue. Feel free to contact us if this tool is useful to you or if you have questions or comments.
This application was built by Innolitics, a team of medical device regulatory consultants and engineers. We can help you get your medical device to market quickly. We provide regulatory strategy and custom software engineering services. We specialize in software-only medical devices (i.e., SaMD) and AI and Machine Learning.
If you like this tool, you may also like MAUDE Alerts or our DICOM Standard Browser.