Just back from Costa Mesa where I spoke at BioCom’s “DeviceFest.” Top billing, however, (and appropriately) went to keynote speaker -- doctor, lawyer, and CDRH chief, Jeff Shuren.
Jeff defended the agency’s actions as of late, restating their dismissal of the IOM report’s call for a wholesale scrapping of the 510(k) process and promoting the various and sundry guidance’s the center is developing to modernize the overall review process. A few verbatims:
· - Relative to the bevy of guidances promised by CDRH, “People will hear what they want to hear – that’s why it’s important to write it down.”
· - His thoughts on the de novo approval pathway, “It’s broken.”
· - Difficult and higher level decisions will not be made “in the bowels of the agency” anymore, but rather by the center’s new Science Council, which is “not a star chamber.”
During the Q&A, I asked Jeff if CDRH will, following the CDER model, formalize a risk/benefit role for patient voices in the review process? His answer, “Yes, in both a qualitative and quantitative way.”
It’s time for the medical device community to stop spending its time and effort blaming the FDA for all its woes and start becoming part of the solution.
Nice job, Jeff.
