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)