Global Regulators, Stakeholders Draft 'Software as a Medical Device' Framework

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A group of medical device regulators and industry stakeholders from 10 countries has released a proposed framework for harmonizing international medical device regulations as they relate to software as a medical device (SaMD). 

"SaMD is increasingly being used in a wide range of medical settings and for a wide range of medical purposes, and has become an innovative tool with the potential to enhance the quality of care," states the document. "There is a need for all stakeholders (manufacturers, users, and regulators) to have a common approach and understanding of SaMD risks and expected controls that promotes patient safety and public health."

The paper was developed by the International Medical Device Regulators Forum's SaMD Working Group chaired by Bakul Patel, senior policy advisor for the U.S. Food and Drug Administration and the primary author of the FDA's final guidance on mobile medical applications released in September 2013. However, Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on FDA regulatory issues, told Health Data Management that the draft SaMD framework and the FDA final guidance on mobile medical apps don't cover the same topic.

"This new document released April 2 is meant to address the next step which is, for apps that are regulated, how should they be regulated," said Thompson. "The whole point of this document is trying to stratify risk to basically--in U.S. vocabulary--decide whether a given piece of software ought to be Class I, II or III. So, it really goes beyond what was addressed in the FDA mobile medical app guidance to get to that question of how should the apps be regulated." 

Regulator and stakeholder members of the SaMD Working Group are drawn from Australia, Belgium, Brazil, Canada, China, France, Germany, Japan, Sweden, and the United States. The purpose of the working group is to develop documents that "provide opportunities to identify commonalities and develop approaches for appropriate regulatory controls, as well as promote prospective convergence in areas of advanced and innovative technologies" pertaining to SaMD. A public comment period for the proposed framework is open until May 31.

"Regulators can utilize this document as a reference when considering their regulatory requirements," states the paper. "The framework is intended only to be used as a foundation and common understanding for SaMD; it is not intended to replace or modify existing classification schemes or regulatory requirements in jurisdictions/countries. Each jurisdiction/country can potentially implement this framework within their respective regulatory approaches, subject to existing legal requirements in each jurisdiction/country."

On the U.S. regulatory front, the FDA, in collaboration with the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology, is currently completing its proposed strategy and recommendations for a risk-based regulatory framework for health IT that includes mobile medical apps. Mandated under the FDA Safety and Innovation Act, the report was due to Congress by January but has been delayed. "That's what the FDA report is supposed to be about--a risk-based framework--and that's what this international [SaMD] report is--a risk-based framework. So, they darn well better overlap," said Thompson, who added that he is "kind of disgusted how long it is taking to issue the FDA report." 

Last month, a bipartisan group of senators sent a letter to the FDA urging the regulatory agency to provide further clarity and transparency in its policy regarding mobile medical apps. “While the FDA’s [September 2013] final guidance has provided clarity on the agency’s approach to regulation of mobile medical applications, we believe more transparency is needed to avoid stakeholder confusion over how a wider range of medical software might be appropriately regulated,” wrote the senators to FDA Commissioner Margaret Hamburg.

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