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FDA Details Preferred Approach To Collecting Diversity Data

 
• By Elizabeth Orr

In a recent guidance document, the FDA explains how trial sponsors should collect and present data on the race and ethnicity of trial participants.

Diversity
• Source: Shutterstock

An expected final guidance document from the US Food and Drug Administration that will require clinical trial sponsors to submit diversity action plans is yet to make an appearance, even though legislation passed in 2022 called for it to be issued by the end of last year. But that doesn’t mean the FDA hasn’t been acting to encourage more diverse study populations.

Most recently, the agency issued a cross-center draft guidance document titled “Collection of Race and Ethnicity Data in Clinical...

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More from Regulation

EU Digital Omnibus Meets MDR And IVDR Revisions: Alignment Or Chaos?

 
• By Amanda Maxwell

Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?

Long-Awaited EUDAMED Notice Ushers In New Era Of Compliance

 
• By Amanda Maxwell

After years of delays - and even skepticism in Rome last month when officials hinted at its imminent debut - the long-awaited EUDAMED medical device database release has finally been confirmed

Proposed Revision Of Digital Rules – EU’s Good Start But Medtech Advises Caution

 
• By Amanda Maxwell

The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?

Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

 
• By Brian Bossetta

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

More from Policy & Regulation

Hundreds Of Adverse Events, Multiple Deaths, Associated With Abbott Correction Of Libre 3 Sensors

 
• By Brian Bossetta

Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.

LDTs Aimed At Catching Cancers Early Hold Promise In Reducing Late-Stage Diagnoses, Study Shows

 
• By Brian Bossetta

A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.

How The EU’s Digital Omnibus Package Could Provide Breathing Space For Medtech

 
• By Amanda Maxwell

The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.