Developing a health app for mobile phones? Then you’re probably wondering if your app is a regulated medical device. Same question if you’re developing any computer software being used in a healthcare setting.
I’ve got good news for you. Not all medical software is an FDA regulated medical device.
Software as a Medical Device (SAMD)
Here’s how the FDA defines a software as a medical device:
[Software] “…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…”Section 201(h) of the Food, Drug, and Cosmetic Act
There are several examples of software that are medical devices hidden within various FDA guides. Here are all the examples I could find:
- Software used to diagnose a disease or other conditions
- Software used to cure, mitigate, treat, or prevent a diseases
- Software, such as a mobile app, used to analyze and interpret EKG waveforms to detect heart function irregularities
- Software to test blood donations for transfusion or transmitted infections
- Software used to determine donor and recipient compatibility
- Blood Establishment Computer Software (BECS) with any of the following functions:
- Determining donor eligibility to donate blood components
- Releasing blood components as suitable for transfusion into patients
- Releasing blood components as suitable for further manufacturing into products for patient treatment
- Providing functions to support blood component transfusion requirements
- Performing blood compatibility testing for blood transfusion
- Providing positive patient identification prior to transfusion
- Recording patient vital signs
- Tracking blood products
- Or any software where a failure of the software’s function could cause risk of death or serious injury to either the patient, user of the device, or others in the environment where the software is used
In general, any software where a failure of the software’s function could cause risk of death or serious injury to either the patient, user of the device, or others in the environment where the software is used.
For reference, I used the following FDA guides to find the examples listed above.