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What A Difference A Year Makes; AI Makes The A-List

 
• By Brian Bossetta

The US FDA’s Center for Devices and Radiological Health has announced the guidance documents it plans to focus on in fiscal year 2024, and this time, AI devices make the cut.

Priority List
• Source: Shutterstock

This time last year, Bradley Merrill Thompson was heartbroken over the Food and Drug Administration’s decision not to prioritize guidance on artificial intelligence/machine learning (AI/ML)-enabled device software functions.

In its annual A and B lists of guidance documents it plans to focus on in the coming fiscal year, the FDA’s Center for Devices and Radiological Health (CDRH) put AI/ML devices on the back burner for 2023, which Thompson, an

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• By Amanda Maxwell

While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.

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

 
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FDA Announces Classifications On 8 Device Types

 
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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.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
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The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.

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Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.

FDA Announces Classifications On 8 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.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.