The FDA’s latest final guidance that affects digital marketers is The Pre-Submission Program and Meetings with Food and Drug Administration Staff Guidance for Industry and Food and Drug Administration Staff. This document talks mostly about physical devices found mainly in hospital settings but also touches on mobile medical applications through its section on the 510(k) process.
The issues discussed in the document touch on some elements of mobile medical apps that are important:
- Software: Is a “moderate level of concern” the appropriate level of concern for my software?
- Human Factors Evaluation: Is my planned approach to human factors assessment appropriate for the intended use of my device?
Anyone looking to run a mobile medical app through the 510(k) process should definitely review this guidance.