FDA Releases Guidance on Software as a Medical Device for Consultation

The US Food and Drug Administration (FDA) on Thursday opened a public consultation on a harmonized guidance on the clinical evaluation of software as a medical device (SaMD) developed by the International Medical Device Regulators Forum (IMDRF).

Proposed Guidance

According to IMDRF, the goal of the guidance is "to establish a common and converged understanding of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of [SaMD]."

Specifically, the guidance provides recommendations for devicemakers on methods of clinical evaluation and the level of clinical evidence necessary to support the use of a SaMD based on previously finalized IMDRF guidance on risk categorization for SaMD, and lays out when SaMD should undergo an independent review.

"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.

However, the guidance states that the recommendations made within 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."

Public Consultation

The proposed guidance was endorsed by the IMDRF management committee following a presentation by Bakul Patel, associate center director for digital health at FDA's Center for Devices and Radiological Health (CDRH) and IMDRF SaMD working group chair at a meeting in Brazil last month.

Now, FDA and IMDRF are asking stakeholders to comment on the guidance before submitting a final version to the IMDRF management committee in February.

In particular, FDA and IMDRF are asking for comment on eight aspects of the guidance:

1. "Does the document address the intention captured in the introduction/scope or vice versa?
2. Does the document appropriately translate and apply current clinical vocabulary for SaMD?
3. Are there other types of SaMD beyond those intended for non-diagnostic, diagnostic and therapeutic purposes that should be highlighted/considered in the document?
4. Does the document adequately address the relevant clinical evaluation methods and processes for SaMD to generate clinical evidence?
5. Are there other appropriate methods for generating clinical evaluation evidence that are relevant for SaMD beyond those described in the document?
6. 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?
7. Are there recommendations identified in section 7.3 related to the "importance of independent review" appropriate as outlined for the different SaMD categories?
8. Given the uniqueness of SaMD and the proposed framework—is there any impact on currently regulated devices or any possible adverse consequences?"

Federal Register notice, Draft Guidance