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Regulatory News | 13 October 2016 | By Michael Mezher
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).
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."
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:
Federal Register notice, Draft Guidance
Tags: Software as a Medical Device, SaMD, IMDRF, International Medical Device Regulators Forum