Software as a Medical Device
(SaMD) Registration in USA

Software as a Medical Device (SaMD) Registration in USA Overview

Answered on this page:

• Is my software a SaMD?
• Which risk class of SaMD requires a 510(k)?
• Software as a Medical Device (SaMD) registration and compliance- The 510(k) Process
• How long is the clearance valid?

Is my software a SaMD?

According to International Medical Device Regulators Forum (IMDRF), SaMD is a

• Software intended to be used for one or more medical purposes and,
• Performs these purposes without being part of a hardware medical device.

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

Determining the Software as a Medical Device (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 will follow for market entry in the US. SaMD is typically categorized into different classes based on its risk level. Class II SaMD is considered moderate risk, requires a 510(k) clearance, and relies on proving the substantial equivalence with the legally marketed predicate device. This clearance process ensures that your SaMD demonstrates substantial equivalence to existing devices, guaranteeing safety and effectiveness before it can be commercialized.

Software as a Medical Device (SaMD) registration and compliance- The 510(k) Process

The 510(k) process involves submitting a comprehensive submission that demonstrates substantial equivalence to a legally marketed predicate device. When a decision is made, FDA issues a decision letter to the submitter by email. A 510(k) application that receives an SE decision letter is deemed “cleared.” It is then listed in the 510(k) database with 510(k) summary as attachment. 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's important to note that the FDA can request periodic reports or additional information to ensure ongoing compliance and safety.

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