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Latest From Ferdous Al-Faruque
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.
In this week's podcast, Medtech Insight’s Ferdous Al-Faruque chats with Elizabeth Orr about the the latest safety concerns over cardiac devices such as drug-eluting stents and implantable cardioverter defibrillators. They also discuss the agency’s recently released user-fee rates and how they’ve increased historically.
US regulators have notified the public about a recall of certain Abbott Ellipse implantable cardioverter defibrillators that are prone to electrical shorting due a manufacturing flaw. While the number of devices so far in the US is very small, the recall highlights continued issues with the ICDs since Abbott acquired them from St. Jude almost three years ago.
Most categories of medical device user fee applications will be 6% more expensive starting in October. Establishment registration fees will see more than a 7% increase as well, regardless of whether a company is considered a small business.
About 130 stakeholders representing a broad spectrum of the health-care industry are asking the US FDA to consider taking a soft touch in any future guidance document addressing artificial intelligence and machine learning devices in order to keep up with developments in the field. Drug lobbyists have also asked the agency to develop guidance that reaches across centers to avoid future conflicts.