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US FDA Draft Guidance Tells Medtech How To Recruit, Report Trial Subpopulations

Medical device makers should be prepared to identify and consider specific differences between patients of varying ages, races and ethnicities, and incorporate queries about subgroups into clinical trial designs and reports supporting 510(k) and premarket approval (PMA) submissions, the US Food and Drug Administration says in a guidance 1,2.

Medical device makers should be prepared to identify and consider specific differences between patients of varying ages, races and ethnicities, and incorporate queries about subgroups into clinical trial designs and reports supporting 510(k) and premarket approval (PMA) submissions, the US Food and Drug Administration says in a guidance 1,2.

The guidance, issued June 20, also directs device sponsors– including those taking the de novo or humanitarian device exemption (HDE)...

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