A tool to help in determining whether your product's software functions are potentially the focus of the FDA's oversight
Review the information below to learn about the Digital Health Policy Navigator before starting the tool.
What is a software "function"?
If you are developing a digital health or software product, it may contain software functions that are considered devices as that term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and are subject to FDA's oversight as devices. Section 201(h) of the FD&C Act defines "device" as 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.
To determine if your product meets the definition of device, you should identify the intended use of your product. Once you have identified the intended use of your product, you can determine the functions and assess whether the product meets the definition of a device. The term "function" means a distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. Products may have one or multiple functions. For example, a product with an intended use to analyze data has one function: analysis. A product with an intended use to store, transfer, and analyze data has three functions: (1) storage, (2) transfer, and (3) analysis. FDA refers to software functions that meet the definition of a device as "device software functions." Software functions that meet the definition of a device may be deployed on mobile platforms, other general-purpose computing platforms, or in the function or control of a hardware medical device.
Many software functions are not medical devices, meaning they do not meet the definition of a device under section 201(h) of the FD&C Act, or are excluded from the device definition by section 520(o) of the FD&C Act, and the FDA does not regulate them as devices. Some software functions may meet the definition of a device, but because they pose a lower risk to the public, the software function may fall within the FDA's intention to exercise enforcement discretion (meaning that the FDA does not intend to enforce requirements under the FD&C Act at this time). The FDA intends to focus its regulatory oversight only on those software functions that are medical devices and whose functionality could pose a risk to a patient's safety if the device were not to function as intended.
Why should product developers use the Digital Health Policy Navigator?
The Digital Health Policy Navigator is a tool intended to help product developers understand whether a software function is potentially subject to or the focus of the FDA's regulatory oversight as a device, and if so, the considerations that may assist in determining the applicable FDA-specific legal and regulatory requirements and recommendations. The Navigator provides an interactive overview of digital health policies that may apply to your product's software functions and accounts for changes to existing medical software policies resulting from section 3060 of the 21st Century Cures Act.
The Digital Health Policy Navigator provides considerations for whether a software function is potentially subject to or the focus of FDA's regulatory oversight as a device. The Digital Health Policy Navigator does not address:
- Considerations on how to design, develop, and test software functions; or
- Considerations relating to the regulation of software used with other medical products (e.g., drugs, biologics), or software intended for other purposes (e.g., electronic consent forms).
What regulatory policies apply to my product?
The Digital Health Policy Navigator was developed to aggregate the FDA's device digital health guidance documents, including those that interpret the 21st Century Cures Act, enacted on December 13, 2016. The Navigator provides a user-friendly resource to help navigate the FDA's existing policies and possible regulatory status of a given software function. The Navigator includes seven steps, each with a set of questions intended to be answered for each of your product's software functions. Your answers to these questions will help guide you through the most relevant FDA medical device regulatory considerations.
For comprehensive policy feedback, complete the steps for EACH of your product's software functions:
- Step 1: Is the software function intended for a medical purpose?
- Step 2: Is the software function intended for administrative support of a health care facility?
- Step 3: Is the software function intended for maintaining or encouraging a healthy lifestyle?
- Step 4: Is the software function intended to serve as electronic patient records?
- Step 5: Is the software function intended for transferring, storing, converting formats, or displaying data and results?
- Step 6: Is the software function intended to provide clinical decision support?
- Step 7: Does the Device Software Functions and Mobile Medical Applications Guidance apply?
At the end of the Digital Health Policy Navigator, there are resources to learn more about the FDA's device digital health guidance documents and to engage with the FDA to receive feedback (see Resources).
What results does the Digital Health Policy Navigator provide?
The results of this Navigator are not a formal FDA device determination for your product. By answering the questions in the Navigator, the results will help you:
- Identify the most relevant laws, guidances, or policies to consider for each of your product's software functions.
- Highlight certain considerations in specific guidances or policies.
After answering the questions for each step, unless the tool directs you to the next step, a possible outcome is provided, at which point the use of the Navigator is complete for that particular software function. The possible outcomes are:
|LIKELY NOT A DEVICE||Device requirements do not apply if the software function is not a device.|
|LIKELY FDA INTENDS TO EXERCISE ENFORCEMENT DISCRETION||Some software functions may meet the definition of a device, but because they pose a lower risk, the software function may fall within FDA's enforcement discretion policy (meaning that the FDA does not intend to enforce applicable requirements under the FD&C Act at this time).|
|LIKELY THE FOCUS OF FDA'S REGULATORY OVERSIGHT||The software function is a device and its functionality could pose a risk to a patient's safety if the device were to not function as intended. Devices may be subject to requirements such as premarket authorization (e.g., premarket notification (section 510(k) of the FD&C Act), De Novo (section 513(f)(3) of the FD&C Act), premarket approval (section 515 of the FD&C Act)), adverse event reporting (section 519 of the FD&C Act), among others.|
|Your product may be a device. Go to Step #.||More information is needed to identify the relevant policies. Go to the next Step.|
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