The U.S. Food and Drug Administration's draft guidance on mobile medical apps is crucial for hospitals creating mobile applications or having apps created for them. Any involvement in creating an app puts hospital executives squarely on the hot seat with the FDA and requires them to meet a host of regulatory requirements.
CIOs have asked FierceMobileHealthcare questions about everything from whether they are considered "manufacturers," to what risk category their apps might fall into, to how they should market or promote their apps to stay within FDA's guidelines.
To that end, we talked with several FDA experts, using their guidance to create this mobile medical apps primer for FDA newbies. Read on to get up to speed on the basic FDA rules, where your apps might fall within them, and how you should respond to ensure your app ultimately is approved for use by patients or clinicians.
Note: The FDA issued draft guidance on mobile medical apps earlier this year, and just received significant comments from groups like the mHealth Regulatory Coalition and others about their content. Our primer, for now, is based on existing rules, and the FDA draft guidance, which could all change next year when the agency is expected to finalize its apps guidance.
Click on any of the links below to get started.
Part I: If you write an app, the FDA will come
Part II: What does the FDA want?
Part III: Intended use - It's all about the message
Part IV: Low-risk apps trending, for now