Thursday, February 12, 2015

FDA Updates & Finalizes Mobile App & Device Guidance

This week the FDA released the final version of their guidance on Medical Device Data Systems (MDDS - original draft was released on June 20, 2014) as well as an update to their guidance on Mobile Medical Applications (last updated on September 25, 2013) to make it consistent with the MDDS document.

I've shared my thoughts on this guidance previously.

For those who aren't familiar with this guidance, the FDA divides mobile medical applications into three categories, only the first of which will be regulated:

Apps that are medical devices

These apps will be regulated, and fall into one of two categories, including those that are either intended:
  1. to be used as an accessory to a regulated medical device; or
  2. to transform a mobile platform into a regulated medical device.
The updated Mobile Medical Applications document provides a number of helpful examples of hypothetical apps as well as a list of approved applications that have gone through the 510(k) process.  Most of these fall into one of the following categories:
  • Apps that use an integrated or attached sensor to obtain data used in medical decision making
  • Apps that use the camera to analyze images and present data used in medical decision making
  • Apps that connect to and alter the behavior of other medical devices (physical connection or remote)
  • Apps used to calibrate medical devices
Apps for which FDA intends to exercise enforcement discretion

These are apps that MAY meet the definition of medical device but likely pose lower risk to the public, therefore they will not be regulated unless decides the app poses a significant patient safety risk.

This is a big deal because all clinical decision support apps will fall into this category. Clinical decision support apps represent one of the most promising categories of medical software, including those that can be integrated into a provider's workflow through integration into the EHR via technologies such as the SMART of FHIR framework.

The FDA realizes that the volume of these apps will likely exceed their capacity to regulate them, but the bottom line is that purchasers and consumers of these applications need to be ever vigilant that what they are using is safe, and immediately report any concerns to the FDA.

Apps that are not medical devices

These are apps the FDA has decided it will not regulate. Types of apps include:
  • Apps that provide medical reference material
  • Apps used as educational tools for medical training
  • Apps used for patient education
  • Apps that automate office operations in a health care setting
  • Apps that are generic aids or general purpose products (e.g., apps that magnify images, record audio, facilitate communication, provide turn-by-turn directions)
For further examples of any of these categories of apps, especially if you're planning to develop a medical app, be sure to check out the full document.

Once again I applaud the FDA for helping clear up some of the confusion regarding regulation of mobile medical applications.  It will be expected, though, that these guidelines will continue to evolve as technology matures.

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