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 Advisory Panel Debates Science On Human Adverse Biological Reactions To Metal-Containing Devices

Executive Summary

US FDA scientists and immunological experts discussed the latest science regarding patients’ biological reactions to metal implants and mercury in dental amalgam at a 13-14 November agency advisory committee meeting. The get-together was held to determine what additional actions the FDA can take to make sure certain patients are protected from immunological risks of the implants. The panel ultimately backed a transition away from mercury amalgam dental fillings and pushed for more research into risks associated with metal implants.

You may also be interested in...



FDA Wants Feedback On How To Properly Label Devices With Risky Materials

The US agency wants stakeholders to chime in on what information should be included in product labels to notify patients about potential side-effects of medical device materials, without being too burdensome for manufacturers.

FDA Guidance: Sponsors Of Nitinol Devices Must Address Thermomechanical Properties Of Alloy

A new FDA final technical guidance on devices containing nitinol spells out special testing considerations and preferred labeling for the medtech products.

CDRH’s Shuren Talks MDUFA, Industry’s Premarket Wants, Emerging Technologies, And More In Wide-Ranging Interview

In an exclusive interview with Medtech Insight, FDA device center director Jeff Shuren said the agency will possibly discuss issues such as postmarket surveillance and patient engagement in upcoming MDUFA negotiations. He also talked about some recent big wins for the agency and his vision for the coming year.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT125907

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