The Food and Drug Administration (FDA) is the governing body for all medical devices in the United States. If you are developing a new software product and are unsure if it is a medical device, then you will need to determine whether your product falls under FDA jurisdiction. In this blog post, we will provide an overview of what constitutes a medical device according to FDA regulations and offer some tips for determining if your product meets these requirements.
1. What is a medical device according to the FDA?
In order to be considered to be a medical device, a product needs to meet a specific set of definitions per the Food, Drug, and Cosmetic (FD&C) Act.
Per Section 201(h) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 520(o).[1]
2. What types of software are not medical devices?
The following software functions fall outside of FDA regulation pursuant to section 520(o)(1) of the FD&C Act and, as a result, are not considered devices.
1) administrative support of a healthcare facility;
2) maintaining or encouraging a healthy lifestyle and are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;
3) serving as electronic patient records to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart;
4) transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a healthcare professional (unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, or findings)
It’s worth noting that the regulatory status of device HARDWARE intended to transfer, store, convert formats, and display medical data and results is regulated by the FDA. [2]
3. How to determine if your software product is a medical device?
A simple step-wise approach could be taken to help you determine whether your software product is a medical device:
Step 1: Define Your Intended Use. In other words, clearly state the general purpose of its function. Then further describe 1) the disease or condition the product will diagnose, cure, mitigate, treat or prevent. 2) the intended patient population.
Keep in mind that the goal is not to make a wish list for what your product may accomplish, but rather it’s preferable to concentrate on a single function.
Step 2: Determine if your product meets the definition of a medical device, outlined in section 1 of this blog. If your product does not meet the definition, it may not be a medical device.
Step 3: Determine if your product is excluded from FDA regulation by referring to the list in section 2 of this blog.
If your software function meets with any of the items on the list, it may not be a medical device.
Step 4: Determine if similar products are regulated by FDA.
If you are aware of products on the market with a similar intended use to your product, look to see if they have regulatory clearance to market on the FDA Medical Device Databases (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases). If there is another product on the market with a similar intended use to yours, and that product is considered as a medical device, then it’s very likely that your product would also be considered a medical device.
Step 5: Determine if your product falls under an FDA product classification
It may be worth looking for medical device classifications (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm) that might apply to your product while determining if it is regulated as a medical device. A previous classification that describes the intended use or design of your product is an excellent sign it could be a medical device.
4. Factors to consider when making this determination
The FDA is taking a tailored, risk-based approach to software functions that have the potential to affect patients’ health negatively. While some software only has minimal consequences, other functions present a greater danger and will thus be subject to closer FDA examination. When in the process of determining the regulatory pathway for your proposed product, some good questions to keep in mind could be “What could go wrong?” and “How would that affect the patient?”
Another key factor that must always be considered is the intended use. Two products could be identical in function and description, but result in different medical device determinations because of their respective intended uses. One example is a mobile app that makes a light-emitting diode (LED) operate. If the manufacturer intends the system to illuminate objects generally (i.e., without a specific medical device intended for use), the mobile app would not be considered a medical device. If, however, through marketing, labeling, and the circumstances surrounding the distribution, the mobile app is promoted by the manufacturer for use as a light source for doctors to examine patients, then the intended use of the light source would be similar to a conventional device such as an ophthalmoscope. [2]
The FDA may exercise enforcement discretion to software functions that meet the regulatory definition of a “device” but pose a low risk to patients and consumers. The FDA will not require manufacturers to submit premarket review applications or list their software with the FDA for these types of software functions.
5. What are some examples of software products that are considered medical devices (per FDA)?
- Software functions that help patients with diagnosed psychiatric conditions (e.g., post-traumatic stress disorder (PTSD), depression, anxiety, obsessive compulsive disorder) maintain their behavioral coping skills by providing a “Skill of the Day” behavioral technique or audio messages that the user can access when experiencing increased anxiety.
–This is an example of a product that meets the definition of a medical device, but due to the lower risk it poses to the public, FDA intends to exercise enforcement discretion for this type of product.
2. Software functions that use a sensor attached to the mobile platform or tools within the mobile platform itself (e.g., accelerometer, microphone) to measure physiological parameters (e.g., limb movement, the electrical activity of the brain (EEG)) during sleep and are intended for use in diagnosis of specific diseases or conditions such as sleep apnea. Possible product code(s): OLV (21 CFR 882.1400), LEL, MNR (21 CFR 868.2375), FLS, NPF (21 CFR 868.2377).
— This example device falls under the category of software functions that are the focus of FDA’s regulatory oversight. It is considered a higher risk as it transforms a mobile platform into a regulated medical device.
3. Software functions that process uterine contraction and fetal heart rate data for remote monitoring of labor progress. Possible product code(s): HGM (21 CFR 884.2740).
— This is another example of a software function that is the focus of the FDA’s regulatory oversight, mainly due to its active patient monitoring for a specific medical condition. [2]
What’s next?
Now that you have a better understanding of what the FDA looks for when determining if a software product is considered a medical device, you can begin to assess your own product.
If you are still unsure or would like to confirm your device determination, be sure to reach out to the FDA for guidance.
The FDA has a variety of centers that may regulate your product, so it’s important to consult with the appropriate center to determine if your product is regulated. Even if your software product does not meet the definition of a medical device, it may still be regulated by another center within the FDA.
References
- https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device
- Policy for Device Software Functions and Mobile Medical Applications, https://www.fda.gov/media/80958/download
