EMERGO SUMMARY OF KEY POINTS:

• US FDA final guidance on clinical evaluation of software as a medical device (SaMD) is now published.
• The guidance utilizes SaMD clinical evaluation principles and recommendations issued by the International Medical Device Regulators Forum (IMDRF).
• US regulators intend to use this guidance as a basis for developing more specific SaMD clinical evaluation guidance in the future.

Medical device regulators at the US Food and Drug Administration have published final guidance on effective clinical evaluation of software as a medical device (SaMD).

The guidance, first issued in draft form in October 2016, is based on principles developed by the International Medical Device Regulators Forum’s (IMDRF) SaMD Working Group. Principles covered in the final guidance are intended as an initial harmonized framework for what the agency and the IMDRF refer to as a “converged approach” to map out clinical evaluation processes for a SaMD product.

Goals of SaMD clinical evaluation

According to the guidance, effective SaMD clinical evaluation should include three major components:

• Valid clinical association between a SaMD’s output and its targeted clinical condition
• Analytical validation showing that a SaMD correctly processes input data and generates accurate, reliable and precise output data
• Clinical validation showing that using a SaMD’s output data achieves the product’s intended purpose in terms of clinical care

SaMD developers should consider clinical evaluations as an “iterative and continuous process as part of the quality management system for medical devices,” as well as the possibility that some SaMD clinical evaluations may require independent reviews in order to verify that products are clinically meaningful to patients and users. In addition, the guidance suggests that SaMD developers monitor safety, effectiveness and performance on a continuous basis via their products’ in-depth levels of connectivity.

Principles regarding the SaMD process

The IMDRF and FDA define SaMD as any software that uses an algorithm operating on data input in order to produce output intended for medical purposes; essentially, risks and benefits of SaMD outputs pertain to how accurate and correct the software’s output data are, as well as how that output data affects the patient’s clinical management.

“Clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a SaMD in order to generate clinical evidence verifying the clinical association and the performance metrics of a SaMD when used as intended by the manufacturer,” states the FDA guidance. “The quality and breadth of the clinical evaluation is determined by the role of the SaMD for the target clinical condition, and assures that the output of the SaMD is clinically valid and can be used reliably and predictably.”

More SaMD specifics coming from FDA

Beyond the final guidance based on IMDRF recommendations, FDA plans to develop its own more specific regulatory framework for SaMD in the future, according to the agency.

Related US regulatory information from Emergo:

• US FDA submission consulting for medical devices and IVDs
• Regulatory consulting for mobile medical apps and telehealth products
• Wireless compliance consulting support for medical device companies
• Regulatory process chart: US FDA medical device registration