Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Outlines Format For Race, Ethnicity Data Collection

Executive Summary

The guidance document tells sponsors to ask about ethnicity before race, and provides suggested wording. It updates a 2005 guidance.

You may also be interested in...



FDA Details Preferred Approach To Collecting Diversity Data

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

US FDA Draft Guidance Tells Medtech How To Recruit, Report Trial Subpopulations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

‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports

The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT104055

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel