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

FDA Panel Says Breast Transilluminators Should Remain Class III

This article was originally published in The Gray Sheet

Executive Summary

FDA’s Radiological Devices Panel recommends that pre-amendment breast transilluminator devices should stay as class III devices.

You may also be interested in...



New PMA Requirement Proposed For Apparently Nonexistent Devices

CDRH is proposing to require PMAs for four categories of devices for the first time, but it is not likely to hear much resistance from industry

FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

Sanofi Prepares Pulmonologists As Dupixent Nears COPD Finishing Line

The French drugmaker has identified education as a key challenge ahead of its June action date for the huge-selling IL4/IL-13 inhibitor in the lung condition. An approval would make it the first biologic for the disease.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT031132

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