Tracking the Presence of Software as a Medical Device in US Food and Drug Administration Databases: Retrospective...

Area of Science:

• Medical Device Regulation
• Health Informatics
• Digital Health

Background:

• Software as a Medical Device (SaMD) is increasingly recognized by regulatory bodies for diagnostic and therapeutic applications.
• Limited data on SaMD prevalence and regulatory actions hinders a comprehensive understanding.
• Understanding SaMD market penetration is crucial for effective regulatory strategies.

Purpose of the Study:

• To empirically assess market approvals and clearances for SaMD.
• To identify and analyze adverse incidents associated with SaMD.
• To provide data-driven insights into the SaMD regulatory landscape.

Main Methods:

• Utilized US Food and Drug Administration (FDA) databases for SaMD registration data since 2016.
• Employed product codes to track SaMD classification pathways.
• Recorded and analyzed adverse event data for SaMD.

Main Results:

• SaMD registration rates are comparable to other medical devices.
• Adverse events related to SaMD constitute a minor fraction of all reported incidents.
• The digital health revolution's impact appears less pronounced in SaMD compared to broader healthcare trends.

Conclusions:

• The growth of SaMD, while noted in literature, has been modest.
• Most SaMD devices are classified as moderate to high risk, following specific regulatory pathways.
• The integration of SaMD into the medical device market largely mirrors that of traditional medical devices.