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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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Your product may be a device. Go to Step 2.

WHY: A device, as defined in section 201(h) of the FD&C Act, can include an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is, among other criteria, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man. Answering "Yes" to Question 1 suggests the software function may meet the device definition.

LEARN: How to Determine if Your Product is a Medical Device

ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.

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LIKELY NOT A DEVICE

WHY: A device, as defined in section 201(h) of the FD&C Act, can include an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is, among other criteria, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man. Answering "No" to Question 1 suggests that the software function may not meet the device definition.

If you are unsure, go to Step 2 to learn about other device criteria and considerations that may apply to your software function.

LEARN: How to Determine if Your Product is a Medical Device

ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.

If your product contains another software function, repeat Step 1 for the next software function.

Feedback: Was the Digital Health Policy Navigator useful? Let us know what you think

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