The AHA today submitted comments on the Food and Drug Administration’s Medical Device Safety Action Plan. Released in April, the plan outlines new pre- and post-market authorities, guidance and an expert board under consideration by the agency to improve device security and how device makers disclose and respond to vulnerabilities. “The AHA supports these steps, which would make important improvements to the FDA’s oversight of medical device manufacturers with respect to the security of their products,” the association said. “We urge the FDA to move as quickly as possible to implement them and make public its timeline for the benefit of all stakeholders.” With respect to guidance, AHA said device manufacturers “must be held accountable to proactively minimize risk by building security into products by design, providing security tools to their end-users and updating and patching devices as new intelligence and threats emerge.” The association also recommended including health care providers as a partner on an expert board being contemplated by the agency.
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Insights and Analysis
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