Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Race/Gender-Specific Densitometry Database Warning Endorsed By Panel

This article was originally published in The Gray Sheet

Executive Summary

Gender and ethnicity-specific databases used with bone densitometry/sonometry devices to assess fracture risk should include cautionary language that their relevance has not undergone sufficient clinical evaluation, FDA's Radiological Devices Panel agreed at a May 17 meeting in Rockville, Maryland.

You may also be interested in...

Bone Sonometry PMAs Need Supporting Data From Caucasian Females

Patient databases used in support of premarket approval of bone densitometry/sonometry devices in assessing fracture risk should consist of Caucasian females 20-29, according to an FDA final guidance.

US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework

Assessment work also isn’t slowing down, the new and generic drug office directors said in an interview, but approval data offers a note of concern.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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