Medical devices are constantly changing due to modifications that are made so they can continuously be improved. The same goes for Software as a medical device (SaMD). Major modifications to the device require premarket review by the FDA, while minor changes likely do not.
A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use. The FDA has published a guide to help stakeholders determine when modifications to legally marketed devices require new premarket notification (510(k)) submissions.
Examples of software modifications that may require a new 510(k) include, but are not limited to, the following:
- A change that introduces a new risk or modifies an existing risk that could result in significant harm
- Changes to risk controls to prevent significant harm
- A change that significantly affects clinical functionality or performance specifications of the device