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


QUOTED. 13 May 2019. Jeff Shuren.

Executive Summary

The FDA's device center director, Jeff Shuren, says the agency has "engaged" with the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) to make sure the regulatory voice "is heard loud and clear" in future standards. See what else he said about that effort here.

"I think that effort will lead to the US FDA adopting more standards. The hope is that it's going to lead to other jurisdictions adopting the same standards and hopefully approaching them ultimately in the same way." – Jeff Shuren, director, US FDA's Center for Devices and Radiological Health

Click here for a free trial of Medtech Insight


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