FDA Regulatory Policies for Software Functionality: An Overview for Innovators, Leaders, and Health Care Professionals
In September 2022, the U.S. Food and Drug Administration (FDA) released significant revisions to guidance documents that provided insights into their current thinking on the regulatory policies for digital health technologies.
The guidance documents clarified the FDA’s interpretation of elements of the Food, Drug, & Cosmetic Act that describes software functionalities that may be exempt from the definition of a medical device. The documents also modified the industry’s current understanding of the regulatory requirements for software-based tools – particularly those that fall within the category of Clinical Decision Support Software.
This overview will empower innovators, leaders, and health care professionals to craft deployment and commercialization strategies for software products that are aligned to FDA’s most recent recommendations.
• Understand FDA regulatory policies for software functionalities.
• Apply the policies to digital health technologies for the purpose of identifying the product’s status as a medical device or non-medical device.
• Know where to find more information about FDA regulatory policies and who to contact for help and support.