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

FDA’s Shuren On Why Agency Broke Up Its IVD And Radiological Health Office

Executive Summary

The US FDA split its Office of In Vitro Diagnostics and Radiological Health in two earlier this week because it “really had two flavors of technology – actually three – that sat in there,” says Jeff Shuren, director of the agency’s device center.

You may also be interested in...



FDA Expands OPEQ ‘Super Office’; Splits In Vitro Diagnostics, Radiological Health Office In Two

The US agency’s Office of Product Evaluation and Quality also created new divisions in its Office of Regulatory Programs and Office of Clinical Evidence and Analysis.

Reminder: Time’s Running Out To Comment On FDA’s Draft Quality Management System Regulation

The deadline is 24 May to comment on one of the biggest regulatory changes in the history of the US FDA’s device center.

Toxins In Silicone Tubing Leads To FDA Warning About Hemodialysis Machines Made By Fresenius

Toxins that have been shown to cause adverse events in animals – including endocrine dysfunction and male reproductive effects – are emitted by tubing that’s part of Fresenius’ 2008T, 2008K2 and 2008K model devices, the US agency says in a letter to health care providers.

Topics

UsernamePublicRestriction

Register

MT145366

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