Software as a Medical Device (SaMD) Registration in the United States (US)

Which risk class of SaMD requires a 510(k)?

Determining the SaMD classification for your software is an important step in the registration process. Once your software has been classified as SaMD, it becomes essential to understand the Regulatory pathway it requires for gaining market entry into the US. SaMD is typically categorized into different classes, based on their risk levels. Class II SaMD is considered moderate risk, requires a 510(k) clearance, and relies on proving substantial equivalence with the legally marketed predicate device. The clearance process ensures that your SaMD is substantially equivalent to existing devices, which helps guarantee its safety and efficacy before it is commercialized.

SaMD registration and compliance – the 510(k) process

The 510(k) process involves a comprehensive submission that demonstrates substantial equivalence to a legally marketed predicate device. When a decision is made, the US Food and Drug Administration (FDA) issues a decision letter to the submitter via email. A 510(k) application that receives a substantial equivalence decision letter is deemed “cleared”. It is then listed in the 510(k) database, with the 510(k) summary attached. The figure below provides a visual overview of the key steps involved in the 510(k) process.

How long is the clearance valid?

A 510(k) clearance remains valid until there are significant changes made to the device or the applicable regulations. However, it is important to note that the US FDA can request periodic reports or additional information to ensure ongoing compliance and safety.

In conclusion, SaMD registration requires a thorough understanding of SaMD classification, SaMD compliance, and Regulatory processes. Seeking SaMD consulting services can provide expert guidance in navigating the complexities and ensuring a successful registration outcome.