The FDA has issued their final guidance on mobile medical applications: Keeping Up with Progress in Mobile Medical Apps. The guidance document (PDF) will “give mobile app creators a clear and predictable roadmap to help them determine whether or not their products will be the focus of FDA’s oversight. ”
The regulatory approach is as you would expect (my highlight):
FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.
There are six categories of mobile applications listed that the FDA intends to exercise enforcement discretion:
- Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
- Provide patients with simple tools to organize and track their health information;
- Provide easy access to information related to health conditions or treatments;
- Help patients document, show or communicate potential medical conditions to health care providers;
- Automate simple tasks for health care providers; or
- Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
If a mobile application is considered a medical device it will be classified as such — class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval) — and the manufacturer will be required to follow Quality System regulations (which includes good manufacturing practices, §820.30) in the design and development of that application.
For any organization that is not already under FDA regulatory control, this is a big deal. Given that there are 1000’s of medical applications already out there, even this limited scope approach will likely affect many companies. More information is here: Mobile Medical Applications.
The guidance includes many examples (including mobile apps that are not medical devices) and an FAQ.