Underscoring the growing importance of software in health care, the FDA has released draft guidance outlining how developers should demonstrate the safety, effectiveness, and performance of software that impacts the clinical management of patients. AAMI reported on this development.
This type of software, called software as a medical device (SaMD), runs on general computing platforms and is not part of a medical device; therefore, it does not come into direct contact with patients. However, the data it analyzes often is used to inform clinical decisions.
“Based on the significant impact SaMD has on clinical outcomes and patient care, a SaMD manufacturer is expected to gather, analyze, and evaluate data, and develop evidence to demonstrate the assurance of safety, effectiveness, and performance of the SaMD,” the guidance states.
The guidance document goes on to provide recommendations on methods of clinical evaluation and the level of clinical evidence necessary to support the use of a SaMD based on its risk categorization.
Instead of representing the thinking only of the FDA, this guidance was developed by an international group of regulators to which the FDA belongs—the International Medical Device Regulators Forum (IMDRF). The FDA noted in a Federal Register notice that over the past few years, a number of initiatives to foster “international harmonization of regulatory requirements” have been undertaken by this group.
According to IMDRF, the goal of the draft SaMD guidance is “to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness, and performance of [SaMD].”
However, the draft states that the recommendations are “not meant to replace or conflict with premarket or postmarket regulatory requirements related to the regulatory classification of SaMD in different jurisdictions” and notes that “the recommendation for independent review for certain categories of SaMD does not imply the need for premarket review (authorization) by a regulatory authority.”
The FDA is asking stakeholders to comment on the draft guidance ahead of the next IMDRF management committee meeting in February, as well as answer a series of questions to gather additional information. These questions are:
- Does the document address the intention captured in the introduction/scope or vice versa?
- Does the document appropriately translate and apply current clinical vocabulary for SaMD?
- Are there other types of SaMD beyond those intended for non-diagnostic, diagnostic, and therapeutic purposes that should be highlighted or considered in the document?
- Does the document adequately address the relevant clinical evaluation methods and processes for SaMD to generate clinical evidence?
- Are there other appropriate methods for generating clinical evaluation evidence that are relevant for SaMD beyond those described in the document?
- Are the recommendations identified in section 7.2 related to the “importance of clinical evidence and expectations” appropriate as outlined for the different SaMD categories?
- Are the recommendations identified in section 7.3 related to the “importance of independent review” appropriate as outlined for the different SaMD categories?
- Given the uniqueness of SaMD and the proposed framework—is there any impact on currently regulated devices or any possible adverse consequences?
Feedback can be submitted through www.regulations.gov until December 13, AAMI officials revealed.