Truly innovative devices that do not have a “substantially equivalent” predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply for approval as low- or moderate-risk devices.
Occasionally a transformative technology comes along that catalyzes a new wave of innovation. The most transformative of which was the internet and the personal computer. Hoping to join that list is 3D printing.
The logic behind the Sunshine Act says that providing clarity on any money that pharma and device makers pay to doctors and hospitals will reduce the occurrence or appearance of corruption. .
The idea is that by making those payments a matter of public record makes it undesirable for companies to try to influence medical experts.
The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.
Baxter is doubling down on diabetes, not a bad bet to make given the global proliferation of the disease and its own overwhelming demand for dialyzers. The company is investing almost $300 million and hiring 200 people to expand its hemodialysis manufacturing in Opelika, AL.
The federal Patient-Centered Outcomes Research Institute added three medical device-related topics to its list of priority research areas that are eligible for enhanced funding under the Pragmatic Clinical Studies initiative.