Guidance for clinical evaluation

The FDA is working on a guide for the clinical evaluation of software as medical devices (SaMD).

The guidance includes recommendations for clinical evaluations, clinical evidence needed for the SaMD and when it needs an independent review.

The SaMD works for patient care, the manufacturer should analyze and evaluate information and then explain evidence to demonstrate the safety and performance of the software.

Please note that the recommendations on the SaMD 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 and the International Medical Device Regulators Forum(IMDRF) are asking for public opinion before approving the definitive version.

There are eight points the FDA and IMDRF would like to consult the public about:

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 is 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?”




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