New FDA Guidance

The FDA issued final guidance explaining how drug companies should develop, distribute, and label apps used alongside prescription medicines.

Three Regulatory Questions

It addresses when app content falls under submission requirements, when software belongs in prescribing information, and what companies submit to FDA.

Apps Connected to Devices

Apps connected to medical devices, such as software paired with an asthma inhaler, generally should be described in official prescribing information.

Standalone App Criteria

Standalone apps belong in prescribing information when companies show they are essential for safe and effective use or offer meaningful clinical benefit.

Most App Content Is Promotional

Separately, most content displayed within companion apps will be treated as promotional material, consistent with FDA's approach to drug advertising.

Who the Guidance Addresses

The framework is aimed primarily at drug companies and technology partners, not at giving patients instructions for using a particular medicine.

Guidance Goals

FDA says the guidance aims to reduce uncertainty for developers and manufacturers while preserving safety and effectiveness standards and supporting evidence-based communication.