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FDA Breakthrough Device Program Nears 800 Designations

 
• By Elizabeth Orr

Almost 800 devices have been granted priority status through the US FDA’s breakthrough devices program, the agency announced this week. But device clearance numbers continue to lag, with only 67 granted as of 31 March.

Brain rocket bursting through horizontal line
• Source: Shutterstock

New data from the US Food and Drug Administration shows the growth of its breakthrough devices program, but may raise questions as to how effective the program is in getting innovative devices to market.

The breakthrough devices program, which launched as the expedited access pathway in 2015, grants regulatory advantages to some innovative devices that treat serious conditions. Products accepted to the pathway may benefit from “sprint discussions” with the FDA about the device development process and prioritized review of future regulatory submissions, among other perks

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With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.

Faster Device Certification Among Keys To Unlocking Innovation In EU MedTech Sector

 
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• By Amanda Maxwell

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FDA Announces Classifications On 9 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

More from Policy & Regulation

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
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The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

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AI Rollout Aims To Accelerate FDA’s Product Review Process

 
• By Elizabeth Orr

The FDA plans to implement artificial intelligence in its scientific review process by 30 June, following a successful pilot. The agency hopes the tool will reduce nonproductive tasks for reviewers amid recent staff cuts. A Chief AI Officer will oversee the rollout and integration.