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

Device Panel Reforms: FDA Puts An End To Approvability Votes

This article was originally published in The Gray Sheet

Executive Summary

FDA advisory panel members will no longer take an up or down vote on the approvability of medical devices, or on recommended conditions of approval, CDRH announced April 26

You may also be interested in...



Further 'Slight Modifications' To Advisory Panel Process Likely

FDA's device center said it will continue to assess its advisory panel process, a week after the first two meetings were held without the traditional up-or-down vote on device approvability

Further 'Slight Modifications' To Advisory Panel Process Likely

FDA's device center said it will continue to assess its advisory panel process, a week after the first two meetings were held without the traditional up-or-down vote on device approvability

Panel Narrowly Recommends Medtronic Spine Treatment After Tough Scrutiny

An FDA advisory panel cast a mixed vote on July 27 in support of Medtronic's Amplify rhBMP-2 Matrix spinal treatment, reflecting disagreement about safety and the reliability of some clinical data

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT028813

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