The number of software as a medical device (SaMD) is growing and with it are questions about how to effectively obtain market clearance for them. One question we hear often is, “Are FDA risk classifications and submissions any different for SaMDs?” Currently, the FDA is regulating SaMDs the same way it’s regulating traditional medical devices. As a result, you’ll still have the same three risk classifications, Class I, Class II, and Class III.

The submission process is also the same. Most Class I devices are 510(k) exempt, and most class II devices would fall under a 510(k) or De Novo submission depending on whether or not substantial equivalence can be made to another US-marketed device. Most Class III devices require PMA submissions.  

There have been discussions about FDA pre-certification programs and following IMDRF guidelines for SaMDs, which would alter the submission process and also the risk stratification of SaMDs. However, none of these discussions have matured. The FDA continues to mirror their risk classification and submission guidelines for SaMDs and traditional medical devices.

Watch the full answer to this question from our recent panel discussion with subject matter expert, Prabhu Raghavan of MDQR Solutions, below.

‍

You can also download the full replay here to get answers to other common SaMD questions such as:  

• How is the FDA regulating AI/ML in SaMDs?
• What is a Predetermined Change Control Plan (PCCP) for machine learning-enabled medical devices?
• What cybersecurity considerations sh ould be made when taking SaMDs to market?

‍