Medtech Insight is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

Third-party inspector program goes international

This article was originally published in The Gray Sheet

Executive Summary

FDA and Canadian counterpart Health Canada are developing a pilot program to allow third-party auditors to conduct inspections that simultaneously assess device company compliance with FDA and Canadian manufacturing regulations. "The idea is that these auditing organizations can do one inspection that will fulfill both Canada's requirements and the FDA's requirements," said Bill Sutton, deputy director of CDRH's Division of Small Manufacturers, International & Consumer Assistance, Sept. 19. FDA would like to expand the program to the EU so that one site visit could cover "three or four regulatory requirements"...
Advertisement

Related Content

FDA’s Third-Party Inspection Program “Here To Stay,” Agency Official Says
Advertisement
UsernamePublicRestriction

Register

MT024023

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

Cancel