Apple will now display on app store product pages in the United States whether an app qualifies as a regulated medical device.
The new labeling applies to health and medical apps that either fall under the “Health & Fitness” or “Medical” categories or contain frequent references to medical or treatment information, as indicated in App Store Connect, according to a March 26 company news release. Developers distributing such apps in the U.S. must now declare their regulatory status and provide supporting details, including safety and contact information.
The requirement takes effect immediately for new apps. Existing apps must comply by early 2027, at which point undeclared apps will be blocked from submitting updates.
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