Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus

Regulatory Explainer: Why and How is FDA Regulating Mobile Apps? - Regulatory Focus:

"In Brief, What's This Issue About?

In the US, the Food and Drug Administration (FDA) regulates many products to ensure that they are safe and effective, including medical devices such as wheelchairs and pacemakers. However, the definition of "medical device" also includes software, and in recent years FDA has moved to regulate software found on mobile phones, what most people refer to as "mobile apps."

Critics have raised the point that strict regulation of medical mobile apps could stifle innovation in the sector, while others have pointed to spurious or faulty apps to make the point that regulation is sorely needed."

'via Blog this'

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Giving FDA.gov Visitors a New Mobile Experience

Updated June 26, 2024

The original link broke.

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Consumer Updates - Science-based health and safety information you can trust - FDA.gov

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Consumer Updates > Giving FDA.gov Visitors a New Mobile Experience:

"FDA just launched a new version of its website that works well with the most popular mobile devices, including smartphones and tablets, while continuing to support traditional desktop and laptop computers."

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FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity

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FDA Issues Final Guidance on Mobile Medical Apps | Medical Connectivity:

"In this final guidance, FDA has chosen to use two factors to distinguish between mobile medical apps that are low risk that they do not intend to regulate, and higher risk apps that will be regulated. FDA will regulate those mobile medical apps intended:

• to be used as an accessory to a regulated medical device; or
• to transform a mobile platform into a regulated medical device."

You might also be interested in:
Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB)

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Recommendations of FDASIA Health IT Workgroup Accepted - FDA Law Blog

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FDA Law Blog: Recommendations of FDASIA Health IT Workgroup Accepted:

"The Food and Drug Administration Safety and Innovation Act (“FDASIA”), signed into law in July 2012, requires the Secretary of Health and Human Services (“HHS”) to "post a report - within 18 months (or by January 2014) - that contains a proposed strategy and recommendations on a risk-based regulatory framework pertaining to health IT, including mobile applications, that promotes innovation, protects patient safety, and avoids regulatory duplication."  FDASIA Section 618."

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