Shuren Calls For Advances in Regulatory Science, Public-Private Medical Device Partnership
Posted 19 January 2012 | By
Jeffery Shuren, the director of the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) commented this week that he believes that the center is becoming more predictable, transparent and efficient, reports Xconomy.
Shuren has been traveling often over the last 24 months as part of a series of "town hall" meetings meant to engage with medical device manufacturers and the public and promote agency accessibility.
Speaking at a meeting in California, Shuren called for manufacturers to engage with CDRH earlier on in the development process in order to expedite the review of medical devices.
Shuren also advocated for advancing regulatory science at the meeting. "If the U.S. wants to remain the leader in medical device innovation, we also must be the leader in regulatory science," said Shuren. This might take the form of improved computer modeling and a public-private consortium used to share proprietary information. While this works well with pharmaceutical companies due to the long development process, this could be more difficult in the medical device sector, said Shuren.
Shuren also commented on the regulation of wireless medical devices and diagnostic devices, noting his concern about the interference and interoperability issues that are possible with wireless devices and the need for accuracy and context for diagnostic devices.