For years there’s been an indistinct, blurry area, surrounding software and apps that are deemed medical devices and so called “wellness” or “lifestyle” applications. Signs of change have emerged over the past few months, in the US at least. And where the US leads, other territories will follow.
It’s probably little surprise, given that software apps rely upon a stable platform to operate effectively.
If, like us, you’ve ever experienced an update to one of the apps on your smartphone either “break” functionality or impact on how another, seemingly unconnected, app performs, then you will appreciate why this is a challenge that needs to be resolved.
FDA publishes and updates guidance documents
Signs of the changes for Software as Medical Devices (SaMD) are mainly found in the activities of the FDA (the US regulator for drugs and medical devices) and forms part of the US government’s drive to bring regulation up to date, by passing the “21st Century Cures Act” into law.
Agency guidances have since been published for a range of topics;
- Multi-function products
- Changes to existing medical device software policies. This impacts upon existing guidance on;
- Clinical and Patient Decision Support Software
Clearly, FDA view the changes as important to the health of the US populace. Taking the case of apps used to support drug treatment as just one example, here’s what the FDA commissioner, Scott Gottlieb had to say;
“Mobile devices and software linked to specific drugs can help patients stay on therapy for treatments where medication compliance is traditionally a challenge”
International guidance for software as medical devices
The flurry of activity comes on the heels of the last in a series of documents produced in the area by the IMDRF (International Medical Device Regulators Forum).
Perhaps you’re not too familiar with the work of the IMDRF? That’s ok, it is after all a rather niche topic. Regulators from the EU and 9 countries have been working together “to develop guidance that supports innovation and timely access to safe and effective Software as a Medical Device”.
Work completed by this IMDRF working group produced a suite of guidance documents relating to SaMD, including;
- Key definitions
- Risk categorisation and considerations
- Application of a QMS to SaMD
- Clinical Evaluation for SaMD
If you’re considering, or are already a long way down the path to, developing, pure software medical devices or “accessory” apps, such as those used to manage a chronic disease such as diabetes, then you need to be aware of the shift and adjust your approach accordingly.
Help is at hand for software as a medical device
Clearly, there’s a lot to take in with the swathe of documents, before assessing the impact the changes may have upon your development plans.
Over the coming weeks, we’ll be sharing insights for each of the documents mentioned in this article.
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Perhaps you want to get to grips with the changes today? Get in touch now.