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Smartphones and tablets have become ubiquitous; most people carry at least one highly capable computer with them everywhere they go and have cloud access to high powered central computers. As technology advances all aspects of health care, software has become an essential part of all products, integrated widely into digital platforms. Software, which on its own is a medical device – Software as a Medical Device (SaMD) – is one of three types of software related to medical devices. The other two types of software related to medical devices include software in a medical device and software used in the manufacture or maintenance of a medical device.
Background Information
SaMD Definition
“Software as a Medical Device” (SaMD) is broadly defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
- SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device;
- SaMD is capable of running on general purpose (non-medical purpose) computing platforms;
- SaMD may be used in combination (e.g., as a module) with other products including medical devices;
- SaMD may be interfaced with other medical devices, including hardware medical devices and other SaMD software, as well as general purpose software;
- SaMD may provide means and suggestions for mitigation of a disease;
- SaMD may provide information for determining compatibility, detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities;
- SaMD be an aid to diagnosis, screening, monitoring, determination of predisposition; prognosis, prediction, determination of physiological status.
Development & Commercialization
Additional Information
Whether using a predictive (Waterfall; V- model) or adaptive methodology (Agile), it is imperative that the following processes and their corresponding outputs to be incorporated in the SaMD Development:
- Software development planning (SDP)
- Requirements analysis
- SaMD architectural design
- Software unit implementation and verification
- Software integration and integration testing
- SaMD verification and validation
- Problem resolution
- Configuration management
- SaMD release & maintenance
- SaMD Design Traceability
- Risk Management Activities
SaMD is still a medical device
Manufacturers of SaMD must report any correction or removal of an SaMD if action was initiated to:
- Reduce a risk to health posed by the device, or
- Remedy a violation of the FDCA caused by the device which may present a risk to health
- Report must be submitted within 10 working days of initiating the correction or removal
- FDA interprets “initiating” the correction or removal as the date a firm makes the decision to initiate a field action (62 FR 27188)
Software as Medical Device
“Software as a Medical Device” (SaMD) has been defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
What is needed to create and launch an SaMD?
- An organizational structure that provides leadership, accountability, and governance with adequate resources to assure the safety, effectiveness, and performance of SaMD
- A set of SaMD lifecycle support processes that are scalable for the size of the organization and are applied consistently across all realization and use processes; and
- A set of realization and use processes that are scalable for the type of SaMD and the size of the organization; and that takes into account important elements required for assuring the safety, effectiveness, and performance of SaMD
Be able to answer the following questions:
- Is there a valid clinical association between your SaMD output and your SaMD’s targeted clinical condition?
- Does your SaMD correctly process input data to generate accurate, reliable, and precise output data?
- Does use of your SaMD’s accurate, reliable, and precise output data achieve your intended purpose in your target population in the context of clinical care?
