Your Fitbit is safe. FDA won't regulate fitness apps - Silicon Valley Business Journal

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Chris Ratcliffe

Mobile applications that help doctors diagnosis illness will be under the FDA's oversight.

Fitness app makers like Fitbit and MyFitnessPal won't have to deal with government regulation after the Food and Drug Administration today said it will only focus on apps that turn mobile phones and tablets into de facto medical devices.

The FDA, which regulates medical devices for mainstream use, issued draft guidance today^[1] on the types of medical apps it will focus on.

The majority of health apps in Google Play or Apple’s App store won’t be regulated — your fitness apps, for example, won’t face scrutiny, nor will your heart-rate monitors. That’s welcome relief for many developers who worried they might fall under the purview of the FDA, long criticized for being stringent and slow.

Which apps will be impacted? Those used in diagnosis or care.

The FDA said it will focus on:

• "Apps intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet."


• "Apps that transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack."

The guidance takes effect on Sept. 25. The FDA will also host a Twitter chat on Sept. 26 and set up an email account to answer developers’ questions.

“We will provide some time for developers to come into compliance,” an agency spokeswoman told me. “Our goal is to help developers understand how to follow our guidance and provide clarity on what they need to submit. Our immediate goal isn’t enforcement but it’s education and compliance.”

The agency has cleared about 100 applications over the past decade, but app makers were looking for more clarity on rules, she added.

Shana Lynch is Managing Editor at the Business Journal. Her phone number is 408.299.1831.

References

1. ^{^} issued draft guidance today (www.fda.gov)