SaMD and the FDA: Definitions and Examples

Introduction

Recently, software has begun to revolutionize virtually every industry and the healthcare industry is no exception. As software becomes increasingly critical to medical devices and technology continues to advance, the software has gradually integrated into digital platforms that serve both medical and non-medical purposes.

According to the FDA, Software as a Medical Device (SaMD)- or software that is a medical device on its own, differentiates between standalone software and software that is part of a medical device.  Classifying SaMD is often arduous. In this post, we will address definitions and examples as well as the transformations that SaMD has and is currently going through.

‍Definitions

SaMD is software that executes (one or more) medical functions and, while the software may be embedded in a piece of hardware, it is the software itself that implements the medical function. According to the  International Medical Device Regulators Forum (IMDRF) (of which the US FDA is a member), the definition of the term Software as a Medical Device is, "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device." They go on to describe SaMD as “software that may work on general-purpose (non-medical) computing platforms; may be used in combination with other products including medical devices; and may interface with other medical devices or other general-purpose hardware and software that provide input to SaMD.”

Furthermore, the FDA states that, “such software was previously referred to by industry, international regulators, and health care providers as standalone software, medical device software, and/or health software, and can sometimes be confused with other types of software.” In other words, software that is essential to the function of hardware, for example, software that helps an X-ray control panel run—isn't SaMD.

Examples

Software as a Medical Device ranges from smartphone apps that calculate insulin doses based on a patient's blood glucose levels, to Computer-Aided Detection (CAD) software that performs image post-processing to help detect breast cancer.

Other examples of SaMD the FDA uses include:

• Software as a Medical Device may be interfaced with other medical devices, including hardware medical devices, and other software as a medical device software, as well as general purpose software. Software that provides parameters that become the input for a different hardware medical device or other Software as a Medical Device. For example, treatment planning software that supplies information used in a linear accelerator is Software as a Medical Device.

• Software with a medical purpose that operates on a general purpose computing platform, i.e., a computing platform that does not have a medical purpose, is considered Software as a Medical Device. For example, software that is intended for diagnosis of a condition using the tri-axial accelerometer that operates on the embedded processor on a consumer digital camera is considered Software as a Medical Device.

• Software that is connected to a hardware medical device but is not needed by that hardware medical device to achieve its intended medical purpose is Software as a Medical Device and not an accessory to the hardware medical device.

• Software as a Medical Device is capable of running on general purpose (non-medical purpose) computing platforms. Software as a medical device running on these general purpose computing platforms could be located in a hardware medical device.

FDA’s SaMD progress

Within the last 5 years, the FDA has made a significant effort to clarify risk-based policies and more clearly communicate its regulatory strategy with the ever-adapting nature of medical devices. In 2017,  the FDA formally announced its digital health innovation action plan, released three new guidance documents, hired an entire digital health team, and launched its digital health software pre-certification pilot program (Pre-Cert pilot program).

These efforts to modernize SaMD, including the FDA's Pre-Cert pilot program aim to, “develop a new approach for a risk-based and accelerated review of digital health products by looking first at the software developer or digital health technology developer, not the product.” Since the program’s launch, the FDA has started data collection to better evaluate their KPIs, recruited 9 pilot participants who represent SaMD developers, and held a 2-day public workshop titled "Fostering digital health innovation: Developing the software pre-certification program."

Promenade Software has people knowledgeable in the nuances of SaMD and the challenges associated with medical device software regulation. If you have questions about the regulation of SaMD or want to learn more about the requirements of the FDA, please check out Promenade Software or contact us.