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VisitNumber of Diversity Action Plans submitted by top 5 medical device makers in 2024
0 • 20%
1 • 20%
2 • 20%
3 • 20%
4 or more • 20%
Public records and announcements from top 5 medical device companies
FDA Issues Long-Awaited Draft Guidance to Improve Diversity in Clinical Trials for Medical Device Makers
Jun 26, 2024, 02:56 PM
The U.S. Food and Drug Administration (FDA) has issued long-awaited draft guidance to improve diversity in clinical trials. Released six months later than expected, the guidance aims to enhance the representation of racial, ethnic, and other underrepresented groups in clinical studies. This initiative is designed to yield a better understanding of treatment effects, improve clinical trial results, and increase trust and participation among diverse populations. The guidance provides detailed instructions for medical product sponsors and medical device makers on how to submit Diversity Action Plans, which are now required for certain clinical studies.
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Top 10% • 25%
Top 25% • 25%
Top 50% • 25%
Below Top 50% • 25%
Top 5 • 25%
6th to 10th • 25%
11th to 15th • 25%
Below 15th • 25%
1 platform • 25%
2 platforms • 25%
3 or more platforms • 25%
No additional platforms • 25%
Increase by more than 5% • 25%
Increase by 0-5% • 25%
No change • 25%
Decrease • 25%
Less than 5,000 • 25%
5,000 to 10,000 • 25%
10,000 to 15,000 • 25%
More than 15,000 • 25%
Less than 100 • 33%
100 to 500 • 33%
More than 500 • 33%
1 new model • 25%
2 new models • 25%
3 or more new models • 25%
No new models • 25%
0-5 partnerships • 33%
6-10 partnerships • 33%
More than 10 partnerships • 33%
Less than 100,000 • 33%
100,000 to 200,000 • 33%
More than 200,000 • 33%
Increase in diversity • 25%
Decrease in diversity • 25%
No significant change • 25%
Insufficient data • 25%
Implement similar rules • 25%
Rescind existing rules • 25%
No changes • 25%
Other actions • 25%
GE Healthcare • 25%
Medtronic • 25%
Johnson & Johnson • 25%
Siemens Healthineers • 25%