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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Panel To Consider If Digital Mammography Is Ready For 510(k)

This article was originally published in The Gray Sheet

Executive Summary

FDA's Radiological Devices Panel will consider reclassifying full-field digital mammography systems as Class II rather than Class III devices nearly a decade after imaging manufacturers first pushed for the classification, which would require a lower threshold of data in premarket submissions

You may also be interested in...



Digital Mammography 510(k) Status Recommended By FDA Panel

Full-field digital mammography systems should be downclassified to Class II, supported by revised guidance as a special control, FDA's Radiological Devices Advisory Panel recommended May 23

Digital Mammography 510(k) Status Recommended By FDA Panel

Full-field digital mammography systems should be downclassified to Class II, supported by revised guidance as a special control, FDA's Radiological Devices Advisory Panel recommended May 23

Digital Mammography More Accurate Than Film For Younger Women – NEJM

Digital mammography is more accurate than traditional film mammography in women under 50 and women with dense breasts, according to a study slated to appear in the Oct. 27 New England Journal of Medicine

UsernamePublicRestriction

Register

OM007016

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