Cybersecurity and U.S. FDA Software as a Medical Device Regulations

The proliferation of wireless, internet, networked and interconnected medical devices as well as software as a medical device (SaMD) has placed cybersecurity issues front and center for manufacturers and developers of such products.

Medical device regulators are working to maintain requirements that will meet the security challenges presented by these devices. The U.S. Food and Drug Administration (FDA) has issued multiple guidance documents to this end in order to address evolving risks related to SaMD and cybersecurity vulnerabilities.

Key factors of FDA SaMD and medical software regulation

In this white paper, Emergo by UL covers key areas including:

• How FDA defines and classifies SaMD 
• Medical software validation and verification considerations, including Software Development Life Cycle (SDLC)
• Cybersecurity and data privacy issues for SaMD and connected medical devices
• Post-market surveillance and vigilance for medical software products

Emergo by UL’s team includes former FDA, European and Asian medical device market regulatory experts able to help manufacturers navigate evolving registration requirements for SaMD.