Classify your software or device at the start of your healthcare app development
journey. Depending on your product's features, it may fall under class I, II, or III, which determines the medical software regulations to execute. The class a device falls into depends on its intended use and, more importantly, its risks. Class I spans devices with the lowest risk and class III — those with the highest.
To determine the product class, you may go directly to the classification database
and search for the device by name. Alternatively, you can go to the panel listing
and search by a panel or medical specialty your device belongs to.
Additionally, since up to 74% of class I devices are exempt from the premarket notification process, check whether it's the case with your product by searching it up on the Medical Device Exemptions
And if you are developing a medical device or SaMD with a completely novel intended use, we recommend contacting FDA directly to discuss what healthcare information technology regulations may apply.