The objective of this document is to provide guidance on clinical evaluation by describing:
- Relevant clinical evaluation methods and processes which can be appropriately used for SaMD to generate clinical evidence;
- The necessary level of clinical evidence for different categories of SaMD; and
- SaMD categories where independent review is important or not important.
The principles discussed are intended to assist SaMD manufacturers and regulators. The principles are based on a common goal to provide confidence to the users of SaMD (patients, providers, consumers, clinical investigators) who rely on the output of SaMD for patient care.
The description of appropriate clinical evaluation methods and processes for SaMD, and recommendations for how much evidence (or degree of certainty of the evidence), and independent oversight is appropriate for SaMD, is not meant to replace or conflict with pre-market or post-market regulatory requirements related to the regulatory classification of SaMD in different jurisdictions. Similarly, the information is not meant to replace, or conflict with, technical or international standards.
In achieving the above objectives, this document relies upon and does not repeat the concepts and principles found in SaMD N12 (risk categorization of SaMD), and SaMD N23 (application of quality management for SaMD), but is a continuum to those documents, and this document should be used in conjunction with those.
The categories of SaMD are limited to the definition in SaMD N10 and the categories of intended use described in SaMD N12 where the information provided by SaMD is intended to inform clinical management, drive clinical management, or diagnose or treat a disease or condition in non-serious, serious or critical healthcare situations or conditions.
This document specifically does not include in its scope or address other types of software used in health care for retrieving information from devices or systems, organizing the collected data, or optimizing healthcare workflow by automating healthcare provider’s care protocols. The scope of SaMD also does not include software that is embedded in a physical medical device or software that is used to provide closed loop intervention.
The guidance provided in this document specifically does not address the regulatory classification of SaMD and does not address whether a premarket clearance is required for a specific SaMD.
This guidance also does not address issues that are generic to all medical devices or specific to a country or jurisdiction such as the following:
- Off-label use or foreseeable misuse;
- Device classification of specific SaMD;
- Whether a pre-market approval or certification is required for specific SaMD.