News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope

This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.

Regulatory News We're Watching
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The first round of pandemic-era guidance documents to be retired after the May ending of the public health emergency are no longer in effect, the US Food and Drug Administration announced on 8 November.

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Draft FDA Reorganization Would Unite All Product Centers

 

Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.

End Of The Road? Court LDT Decision May Leave FDA With Few Options

 

Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?

Pushing On An Open EU Door? Time For MHRA To Get Practical About UK’s Regulatory Ambition

 
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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.

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

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UK Treading A Tightrope On Trump’s Tariffs

 
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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.

Medtech Industry Faces Tariffs Despite Pleas for Exemption

 
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Medical devices, diagnostics, and equipment face tariffs announced by President Donald Trump, despite industry pleas for exemption. The tariffs, ranging from 10%-49%, impact most countries trading with the US, potentially hindering innovation and increasing costs in the medtech sector.

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.