Frequently Asked Questions

What happens with the FDA when there are changes and updates to a SaMD device?

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Compliance & Regulatory: MedTech
FDA Clearance
Guidelines & Standards

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