As technology continues to advance all facets of health care, software has become an important part of all products, integrated widely into digital platforms that serve both medical and non-medical purposes. Software, which on its own is a medical device – Software as a Medical Device – is one of three types of software related to medical devices. The other two types of software related to medical devices include software that is integral to a medical device (Software in a medical device) and software used in the manufacture or maintenance of a medical device.
What is Software as a Medical Device?
The term Software as a Medical Device is defined by the International Medical Device Regulators Forum (IMDRF) as "software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device."
Use of Software as a Medical Device is continuing to increase. It can be used across a broad range of technology platforms, including medical device platforms, commercial "off-the-shelf" platforms, and virtual networks, to name a few. 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.
How are Regulators Addressing the Challenges with Software as a Medical Device?
Given the unique features of Software as a Medical Device that extend beyond a traditional medical device or hardware, regulators across the globe recognized the need to converge on a common framework and principles for Software as a Medical Device that enables all stakeholders, including regulators, to promote safe innovation and protect patient safety.
The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to reach harmonization on medical device regulation. IMDRF develops internationally agreed upon documents related to a wide variety of topics affecting medical devices. In 2013, IMDRF formed the Software as a Medical Device Working Group (WG) to develop guidance supporting innovation and timely access to safe and effective Software as a Medical Device globally. Chaired by the FDA, the Software as a Medical Device WG agreed upon the key definitions for Software as a Medical Device, framework for risk categorization for Software as a Medical Device, the Quality Management System for Software as a Medical Device, and the clinical evaluation of Software as a Medical Device.
- November 2018: Federal Register Notice “Prescription Drug-Use- Related Software” announced the establishment of a docket to seek early input from the public on the agency’s proposed framework for prescription drug-use-related software
- Software as a Medical Device (SAMD): Clinical Evaluation - Guidance for Industry and Food and Drug Administration Staff