The Food and Drug Administration (FDA) recently released guidance on how the agency intends to regulate mobile applications (“mobile apps”). This more complete guidance follows the FDA’s May 21“It has come to our attention” letter to Biosense Technologies regarding a mobile app that can conduct urine analysis. Given the growing expansion and applicability of mobile apps, this recent guidance contains non-binding recommendations aimed to provide clarity and predictability for manufacturers of mobile medical apps.
The FDA intends to focus its regulatory oversight to only those mobile apps that are medical devices (as defined in the FD&C Act) and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. Referred to as “mobile medical apps,” these include mobile apps that:
- Connect to an existing medical device for purposes of controlling the device or displaying storing, analyzing, or transmitting patient-specific medical device data;
- Transform the mobile platform into a regulated device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices; or
- Become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis or treatment recommendations.
For other health-related mobile apps that pose a low risk to patients, the FDA intends to exercise “enforcement discretion,” meaning the agency does not intend to enforce requirements under the FD&C Act. These include mobile apps that:
- Provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference);
- Help patients document, show or communicate to providers potential medical conditions;
- Perform simple calculations routinely used in clinical practice; or
- Enable individuals to interact with PHR or EHR systems.
Depending on the classification and the associated regulation for the mobile medical app, a manufacturer would be required to follow a set of regulatory controls. The guidance contains more specific examples of mobile medical app classification and some helpful FAQs. Specifically, the guidance contains appendices including what the FDA does and does not consider as medical devices and a list of medical devices posing a risk of harming a patients if they malfunction. For more information regarding FDA guidance on mobile apps specifically, please contact Jefferson Lin.