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

UsernamePublicRestriction
UsernamePublicRestriction

Stacking Bricks: FDA Unveils Structure For New Office Of Product Evaluation And Quality, Touts Benefits Of OPEQ

Executive Summary

US FDA's Sean Boyd gave an inside look at how the agency plans to organize its Office of Product Evaluation and Quality (OPEQ) – the so-called "super office" that will consolidate a handful of current, distinct offices that handle pre-market, compliance, enforcement and post-market surveillance activities. Plus: Five expected benefits for device-makers (and five for FDA) under the OPEQ reorganization are highlighted.

You may also be interested in...



FDA Device Center Reorg Set To Roll Out This Week

US FDA's Center for Devices and Radiological Health will finally launch a long-planned reorganization that will see agency staff grouped by device types, rather than by stage in the device-review cycle. The reorganization begins this week and should be complete by Sept. 30.

Molecular Dx Exec Named New US FDA Diagnostics Chief

Timothy Stenzel brings experience developing and commercializing new molecular diagnostics, including companion tests, and running a clinical laboratory to his new role as director of US FDA's Office of In Vitro Diagnostics and Radiological Health.

US FDA Centers Will Report Directly To Gottlieb: 'Flattened' Structure Will Make Future Political Transitions Easier

Principal Deputy Commissioner Sherman remains top policy guru and will oversee consolidation of functions currently scattered throughout FDA into the Office of Operations.

Related Content

Topics

UsernamePublicRestriction

Register

MT122154

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