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

CDRH Compliance Office Seeks Inroads With FDA Office Of Regulatory Affairs

This article was originally published in The Gray Sheet

Executive Summary

The top near-term contribution of the Office of Compliance to CDRH's postmarket reform effort will be trying to improve its working relationship with FDA's Office of Regulatory Affairs

You may also be interested in...



CDRH Unveils Postmarket Safety “Action Items”

FDA's plan to strengthen postmarket device safety by making better use of postmarket data includes modifying its organizational infrastructure, updating adverse event reporting practices and potentially increasing the use of fines for certain types of industry noncompliance

FDA Will Customize Foreign Facility Inspections To Improve Efficiency

FDA inspectors will take a more customized approach to auditing foreign device manufacturing facilities in 2006 to improve the efficiency of costly overseas trips, device center Office of Compliance Director Tim Ulatowski suggests

OC FY 2005 Priorities: MDUFMA, Bioterror, Closing Out Enforcement Actions

Fiscal 2005 marks the inaugural year for the CDRH Office of Compliance's new inspection planning process, an initiative that reflects FDA's emphasis on risk-based regulation

Latest Headlines
See All
UsernamePublicRestriction

Register

MT024222

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