WASHINGTON – Jeff Shuren, the new director of the Center for Devices and Radiological Health has made extensive time in his schedule for communicating with industry, and this year's annual conference by the Food and Drug Law Institute (FDLI; Washington) served as yet another forum for the new device chief. He reviewed a number of issues raised by device makers since he took the job, but one comment he made may suggest something about why industry sees the center as less responsive. Shuren informed the audience that while agency employees are instructed to respond promptly to industry inquiries, other issues may supersede this and other short-term priorities. (Medical Device Daily)

WASHINGTON – FDA Commissioner Margaret Hamburg, MD, opened the plenary session on the first day of the 53rd Annual FDLI Conference, hosted by the Food and Drug Law Institute (FDLI; Washington), and she made it clear at the outset that the agency will not hesitate to ask Congress for additional statutory authority should she conclude that such a request would be appropriate. On the other hand, the agency's new chief counsel, Ralph Tyler, also made a point very clear, that his office would do its best to facilitate enforcement action even in the absence of direct statutory authority, assuming that the intended action does not explicitly run afoul of the statute. (Medical Device Daily)