Is my Software a Medical Device? Use the Digital Health Policy Navigator

With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA).  If you are a manufacturer of implants that go into the human body for the treatment of disease, it’s an easy yes that you are a manufacturer of a medical device. But, for software products, it is often not straightforward to address this question by simply referring to the statutory definition of a device. Determining whether your product meets the definition of a medical device has significant implications, such as whether you need to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This blog post describes the medical device determination process and a way of assessing software functions to determine if your software product is subject to FDA regulations.  While the methodology for determining if your product is a medical device has not changed, FDA’s Digital Health Policy Navigator (“Navigator”) provides a convenient and efficient framework for developers to assess software functions.  This interactive 7-step process guides developers in assessing each discrete software function in a product.  It identifies key questions to consider that originate from a variety of FDA guidance documents and aggregates the information into a one-stop shop. While the Navigator should not be used in place of seeking regulatory advice, it is a helpful tool to review when determining what features of a software product may be subject to FDA oversight.

Medical Device Determination Process

The first step of the device determination process is to compare the intended use and indications for use of your product against the above statutory definition of a device (see here).  Section 201(h)(1) of the FD&C Act defines a medical device, in pertinent part, as an “instrument, apparatus, implement . . . or other similar or related article” which is “intended for use in the diagnosis of disease or other conditions.”  Note that section 201(h)(1) of the FD&C Act ends with the sentence “[t]he term “device” does not include software functions excluded pursuant to section 520(o).”

Thus, the second step is to determine if an appropriate product classification exists for your product. This can be done by either searching the FDA Product Classification Database or searching for similar devices. Please check out FDA’s presentation on this very topic – Is My Product a Medical Device? (See here for the slides, here for the recording of the presentation, and here for the transcript.)

In case your product meets the definition of a device but an appropriate product classification is not identified, you may need to submit a de novo classification request to FDA. Also, even if your software product meets the definition of a device, there is a chance that your product meets one of the five carve-outs described below.

Section 3060(a) of the 21st Century Cures Act amended the FD&C Act to add section 520(o), which provides carve-outs from the definition of device in section 201(h)(1) of the FD&C Act.  These are functions that are intended for (1) administrative support of a health care facility, (2) maintaining or encouraging a healthy lifestyle, (3) serving as electronic patient records, (4) transferring, storing, converting formats, or displaying data and results, and/or (5) providing clinical decision support. Manufacturers of software products should determine whether their software functions are excluded from the definition of a device.  If the software functions do not meet the definition of a device under section 201(h)(1) of the FD&C Act or are excluded from the device definition by section 520(o) of the FD&C Act, FDA does not regulate them as devices.

There are multiple resources that FDA provides to facilitate the understanding of the Agency’s thinking regarding the amended device definition and the interpretation of section 3060(a) of the Cures Act, including sections 520(o)(1)(A)-(D) of the FD&C Act.  The following Guidance documents are critical to understanding the FDA’s policy for software products:

• Changes to Existing Medical Software Policies
• General Wellness: Policy for Low Risk Devices
• Policy for Device Software Functions and Mobile Medical Applications
• Clinical Decision Support Software
• Off-The-Shelf Software Use in Medical Devices
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
• Multiple Function Device Products: Policy and Considerations

Digital Health Policy Navigator Tool

FDA  developed the Digital Health Policy Navigator (Navigator) to aggregate the FDA’s digital health guidance documents into one user-friendly resource.  The Navigator guides manufacturers in their assessment of whether a particular software function meets the device definition and if so, whether it is the focus of FDA’s regulatory oversight. A software function is the distinct purpose of the product which could be the intended use or subset of the intended use of the product.  The Navigator is designed as an interactive overview with seven simple steps, each with a set of questions that should be answered for each software function.  It then identifies the applicable laws, guidances, and policies that may apply.

• 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 family?
• 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 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?

The possible outcomes from the Navigator are:

• Likely not a device
• Likely FDA intends to exercise enforcement discretion
• Likely the focus of FDA’s regulatory oversight
• Your product may be a device

Below, we reproduced the Navigator’s process in a flowchart format so that our blog readers can quickly arrive at an outcome and its implications for their software product. The flowchart can be downloaded here. For detailed explanations for each step, please refer to the Digital Health Policy Navigator. We appreciate FDA’s efforts to aggregate relevant resources so that manufacturers can more easily identify whether their software products are subject to regulation.