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  4. Step 1: Is the Software Function Intended For a Medical Purpose?
  1. Digital Health Center of Excellence

Step 1: Is the Software Function Intended For a Medical Purpose?

Digital Health Policy Navigator - Step 1

Before starting the navigator, identify the software functions included in your product so that you can complete the steps for EACH of your product's software functions.

A product is a device, and subject to FDA regulation, if it meets the definition of a device per section 201(h) of the FD&C Act. To help determine if your product meets the definition of a device, you should identify the intended use of your product, including any disease or condition, and patient population.

The words "intended use" refer to the general purpose of a product, which is the objective intent of the persons legally responsible for labeling of a product (or their representatives). This intent may be shown by expressions, the design or composition of the product, or by the circumstances surrounding the distribution of a product. To learn more about the meaning of intended use, refer to 21 CFR 801.4.

Step 1 will help determine if your software function meets the definition of a device.

1. Is the software function intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in humans?

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