By Stewart Eisenhart, Emergo Group
Highly anticipated final guidance issued by the US Food and Drug Administration indicates a limited approach to regulating mobile medical apps, with no plans by the agency to enforce Federal Drug & Cosmetic Act requirements for most of these products.
Furthermore, the FDA intends to regulate mobile medical apps using its existing registration process for medical devices rather than develop new requirements specifically targeting apps.
Only medical apps that could pose risk to patient or user safety will warrant FDA regulation, according to the guidance: Apps acting as accessories to regulated medical devices, and apps that change the function of a mobile platform to that of a regulated device.
Examples of mobile apps not targeted by the FDA
The FDA identifies broad categories of mobile apps it does not consider medical devices, including:
- Apps that provide access to electronic copies of medical textbooks, dictionaries or other reference sources
- Apps used for medical training or education
- General education apps for patients
- General office management and health care administration apps
Also listed in the guidance are examples of mobile apps the FDA does consider medical devices, but for which the agency does not intend to apply registration requirements due to their low risk profiles. Examples include apps used to track asthmatic episodes, record clinical conversations between healthcare providers and patients, and apps used to send emergency notifications to first responders.
Mobile medical apps the FDA will regulate
Types of mobile medical apps that US regulators do consider risky enough to warrant oversight include the following:
- Any app that transforms a mobile or technology platform into a medical device
- Any app that connects to another medical device to control the other product’s operation or energy source
- Any app that displays, transfers or stores patient-specific medical device data
Developers of such mobile medical apps will need to investigate whether they’ll need to submit FDA 510(k) premarket notification or Premarket Approval (PMA) registration applications, as well as establish compliance with FDA Good Manufacturing Practice (GMP) quality management system rules.
Bottom line: The FDA’s final guidance for mobile medical app regulation should contain few (if any) surprises for medical technology industry participants. The regulator’s limited approach to such devices using existing, familiar registration requirements provides a clearer and more predictable path to market in the US for medical app developers.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.