Revised FDA Device Guidance Removes Diversity References

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Revised FDA Device Guidance Removes Diversity References

J.W. Schomisch

April 4, 2025 at 11:56 AM EST

The FDA March 31 released a revised guidance dealing with the evaluation of sex-specific data in medical device clinical studies that added no new information but rather removed information regarding race, ethnicity and sexual orientation. The guidance, which was originally issued in August 2014, is designed to encourage the consideration of sex and associated covariates (e.g... Read More

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Revised FDA Device Guidance Removes Diversity References

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