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 Center Director Advocates Getting “Experimental” With Third-Party

This article was originally published in The Gray Sheet

Executive Summary

The Center for Devices and Radiological Health is looking to assess how third-party and FDA review of 510(k)s compare

You may also be interested in...



CDRH Open To Third-Party Review Of 510(k)s With Clinical Data

CDRH leadership would not oppose a legislative amendment to allow third parties to review 510(k) applications that rely on clinical data, according to center director David Feigal.

‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation

CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.

Biogen Sees Improving Momentum In Slow Leqembi Launch

Sales of the company’s new drugs have a lot of growing to do to make up for older products’ declines, but Biogen highlighted signs of strength for new launches in its Q1 report.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT016436

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