Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing
This article was originally published in The Gray Sheet
Robert Califf responded to questions about improving postmarket device surveillance during his Nov. 17 confirmation hearing, including from HELP Committee Ranking Member Patty Murray, D-Wash., who raised the issue in relation to tainted duodenscopes that led to the deaths of several people in her state. Califf also addressed questions on lab-developed test oversight and charges that FDA overuses guidance documents.
You may also be interested in...
The Senate confirmed Robert Califf as the new FDA commissioner after months of delay, giving the cardiologist, clinical trial expert and established agency official a better platform to push his priorities, which include combination product and clinical data-collection reforms, while implementing projects already under way.
Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.
The Senate Health, Education, Labor and Pensions Committee plans a confirmation vote on Robert Califf Jan. 12 to become the next FDA commissioner. Public health researchers and Sens. Sanders and Warren have argued that the long-time academic research leader's ties to industry are too close. Meanwhile, Califf recently has emphasized his focus on strengthening postmarket safety oversight.