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


FDA Manufacturing-Change Reviews Will Shift From Compliance Office To ODE

This article was originally published in The Gray Sheet

Executive Summary

The move is in line with the agency’s intention to focus on the total product life-cycle, such that the same staffers that review an original marketing submission will look at the safety and effectiveness of manufacturing changes.

You may also be interested in...

CDRH’s Division of Cardiovascular Devices Starts 30-Day Notice Reviews

The division officially began taking over reviews of 30-day manufacturing notices from the Office of Compliance Feb. 1 as part of a larger reorganization.

ODE Reorganization Reduces Reviewer-To-Manager Ratio

A restructuring in the Office of Device Evaluation, incorporating dozens of new hires, is intended to reduce the number of reviewers reporting to each manager. It took effect last week.

Regulatory News In Brief

PMA-supplement guidance

Related Content





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