FDA Adopts Proposals by the IMDRF for the Clinical Evaluation of Software as Medical Device
The proposals by the International Medical Device Regulators Forum (IMDRF) regarding the clinical evaluation of software as a medical device have been incorporated into a new draft guidance by the US Food and Drug Administration.
In a document issued in August 2016, the IMDRF proposed some specific clinical evaluation processes for software as a medical device (SaMD) in order to determine safety, effectiveness and performance.
Clinical evaluations are required for all medical devices. However, some additional recommendations have been proposed for SaMD due to software’s unique characteristics, such as indirect contact with patients and its operating in a complex environment in which product modifications occur at a much faster rate than for conventional devices.
Three categories of SaMD have been determined according to how the software output affects healthcare decisions:
- SaMD informing clinical management: These products provide information on diagnosis or treatment options, or aggregate clinical data from various sources
- SaMD driving clinical management: These products aid in treatment, prediction or diagnosis of a disease or condition
- SaMD treating or diagnosing: These products directly treat, diagnose, screen, prevent or mitigate diseases or conditions, and their use may lead to immediate or near-term actions by healthcare providers or users
According to the IMDRF, clinical evaluations should be planned by manufacturers or developers prior to being conducted on a SaMD product, and incorporate appropriate risk assessment data and processes pertaining to that product.
The extent of the evaluation depends on several factors: the SaMD’s underlying algorithm, that algorithm’s degree of transparency, characteristics of the SaMD’s intended use target population and intended users.