FDA Wants $18M To Update Outmoded Device Program IT Systems
The US agency says its medical device program is in desperate need of an information technology upgrade, noting that its outdated IT systems, tools and approaches could leave it flat-footed when dealing with cybersecurity threats and ever-evolving medtech. That’s why the FDA is asking Congress for $18m to tackle the IT sore spot.
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FDA’s Device Center Could Raid $2.8M From Staff Outreach, Training Kitty In 2021 To Fund Other CDRH Needs
While the Trump administration’s proposed fiscal year 2021 budget for the US FDA would give the agency’s device center a 5.3% increase for medtech product approvals and safety, the center’s lofty plans to become the world’s premier regulator of new AI-driven gadgets, next-gen diagnostics and other novel devices means it will have to tap about $2.8m dollars usually set aside for staff training and outreach to help meet its ambitious goals.
As principal deputy commissioner of the FDA, Amy Abernethy is focused on developing overarching policies that affect all its product centers. But perhaps what will stand as her legacy is her work to develop a data-centered strategy to improve how the agency reviews products and ensures their long-term safety and efficacy.
Amy Abernethy, the principal deputy commissioner at the US FDA, told attendees at a 25 July medical conference that she's somewhat skeptical about using wearable technologies for clinical needs because they still haven’t proven their accuracy. However, she says the device center is working hard to develop new standards for such products and is looking for funding to develop them.