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


CDRH matrix team likely to be scrapped

This article was originally published in The Silver Sheet

Executive Summary

Two years after going live, CDRH's matrix team - a structure of network leaders tasked with keeping pre- and post-market offices communicating - is likely on its way out. "We did an internal assessment of the matrix structure and concluded it is probably not the best organization [for us] right now," CDRH Director Jeffrey Shuren said at a June 22 FDA "town hall" meeting in Woburn, Mass., noting that the matrix "is very challenging to maintain." CDRH plans to issue a report soon that will explore alternative organizational options, he said. The matrix brings together pre-market reviewers, adverse event analysts, scientific researchers and others to evaluate safety risks for different device types ("The Silver Sheet" September 2009). Although the matrix may not be the answer, Shuren affirmed that the goal of breaking down barriers between "siloed" groups within the center is correct. He cited the recent creation of two new deputy director positions in the Office of the Center Director, one for science and one for policy, as a step toward greater alignment on those issues throughout CDRH's various offices. Those posts have yet to be filled, however





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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