In Case You Missed It: Top 10 "Gray Sheet" Stories In December
This article was originally published in The Gray Sheet
Our most popular stories in December included an in-depth exploration of best practices in setting up an effective "war room" during an FDA inspection; a detailed look at user-fee reauthorization proposals early in the negotiation process; updates from the agency's Office of Regulatory Affairs, Office of Compliance, and Office of Device Evaluation; and more.
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As the number of de novo applications and pre-submission consultations keep growing, FDA is proposing to institute provide new funding for these programs, among a range of additional proposals laid out in a recent closed-door negotiation. The agency's plan aligns somewhat with an industry proposal, according to meeting minutes, but there is also a lot to negotiate.
A patent review board found that a remote monitoring patent owned by a “non-practicing entity” was invalid due to obviousness. So-called "patent troll" cases had been relatively rare in the device arena, but there has been an increase in activity.
The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.