Wellness and Mobile Health Technologies

FDA Oversight of Mobile Medical Applications

In Development.

Mobile Apps not Considered "mobile medical device"

If the decision is made to not pursue regulation, the marketing must be carefully reviewed to ensure that it does make health claims. If decision is made to pursue regulation, innovators can file a 513(g) petition to obtain a formal determination on whether the product classify as a medical device.

(Optional) Action: Submit an Inquiry or 513(g) Petition

Case Study: 23andMe

Enforcement Discretion

In Development.

Mobile Medical Apps

In Development.

Software as a Medical Device

In Development.

Resources: Wellness and Mobile Health

Version History

• 02.04.2017 Initial Revision.

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