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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.
Latest From United States, Policy & Regulation
An ongoing recall of Edwards Lifesciences’ Sapien 3 Ultra transcatheter heart valve system has been elevated to Class I, indicating the US FDA’s highest risk level.
The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.
Danish device-maker Ambu has agreed to pay $3.3m to resolve allegations of False Claims Act violations. The company is said to have made medical product in Malaysia and China for sale to the Departments of Defense and Veterans Affairs, which is forbidden under the Trade Agreements Act.
Medtech firms couldn’t convince the US Medicare agency to propose additional temporary payments under Medicare for non-opioid pain management device alternatives in its proposed rule for outpatient hospitals and ambulatory surgical centers. In response, industry advocacy group AdvaMed plans to gather more data in support of payment incentives before a mid-September deadline comes for comments on the rule.
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.
The US Medicare agency approved a new technology add-on payment (NTAP) for T2 Biosystems’ blood test, the T2Bacteria panel, for the fiscal year that will begin on 1 October.
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