Findings
The use of Intended Use and Indication for Use is crucial for digital health products to ensure the product is used appropriately and effectively to meet the needs of the intended population. This information helps establish clear expectations for a product’s performance and safety, facilitates regulatory approval, and ensures compliance. The Intended Use provides a general description of the digital health product’s purpose or function. The Indication for Use describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population. A change in a product’s indication for use from general to specific usually results in a narrower indication concerning function, target population, or disease entity. Levels of specificity for diagnostic and therapeutic products can be categorized, ranging from the identification of a physical parameter (most general) to the identification of an effect on the clinical outcome (most specific).

Recommendations
The Intended Use statement should include the name of the product, the medical purpose, and what it is trying to do for the user. The Indication for Use statement should include the name of the product, the specific condition or disease state it is addressing, the patient population being targeted, what the product features do, whether other technology components are used with the product, and whether it is for “prescription” or “over-the-counter” use. Developers should characterize the users (e.g., by age, knowledge, or language) and describe the usage context (e.g., hospital ward, emergency room, web-based app). The Indication for Use statement should clearly state the product’s clinical capabilities and what it is not intended for (e.g., not intended to provide a diagnosis or replace traditional methods).

Regulatory Considerations
The information provided in the Intended Use and Indication for Use statements is used to inform the product’s design and development, as well as to guide regulatory decisions about its approval and marketing. Defining these statements facilitates the regulatory approval process and helps ensure compliance with relevant regulations and standards. The FDA defines the levels of specificity as a qualitative ranking of the proposed indications for use. The document provides examples of FDA’s “Indications for Use” from submissions, such as the use of an Atrial Fibrillation History Feature, illustrating the necessary detail for regulatory submissions like a 510(k).