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
- Find out more: FDA Official: QSR/ISO 13485 Mash-Up On Track But Will 'Take Time'; CDRH's Shuren Open To 'Adopting More Standards'
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