Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Global Regulators, Stakeholders Draft 'Software as a Medical Device' Framework."
Following is an excerpt:
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.” …
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.”
