The US Food and Drug Administration recently announced it is set to expand the Total Product Lifecycle Advisory Program (TAP) by enrolling devices from the Office of Neurological and Physical Medicine Devices (OHT5) beginning 1 October.
FDA To Expand TAP Pilot Program
The US Food and Drug Administration is set to expand a pilot program aimed at speeding up the development of innovative medical devices. The agency will begin enrolling more devices in the Total Product Lifecycle Advisory Program, which the agency rolled out in January.

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The UK’s “New Approach” to regulation has created a lot of noise, but what’s the end product? asks Taylor Wessing partner Alison Dennis, who says the UK medtech regulator should look afresh at the EU’s ready-made solution.
US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.
Medtech has not yet been spared from the Trump administration’s trade tariffs, which, for UK exporters will be 10% – half the rate applied to EU27 exporters.