MASSDEVICE ON CALL — About 100 submissions to the FDA’s Center for Devices & Radiological Health languished during the 16-day shutdown of the federal government earlier this month, meaning it won’t meet its review goals, the agency told stakeholders.
Any submissions for 510(k) clearance or pre-market approval received between Oct. 1, when the shutdown began, and its end on Oct. 16 will be marked as received Oct. 17, Bloomberg BNA reported.
And the CDRH expects to receive a backlog of applications that companies may have held up while the shutdown was under way, according to the news service.
"FDA has communicated its status and plans for addressing any backlog caused by the recent government shutdown. The agency has given no indication that it will be unable to meet its performance goals under the new user fee agreement," Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, told Bloomberg BNA.
A potential ‘doc fix’ is in
Democratic and Republican leaders of 2 key congressional committees agreed on a framework to replace the Medicare payment formula for physicians with a plan to link physician reimbursement to quality of care – a so-called "doc fix." The discussion draft released yesterday by the Senate Finance and House Ways & Means committees would do away with the Sustainable Growth Rate, shifting from payment for volume and to financial incentives designed to emphasize the quality of care. The framework would hold doctors’ pay at current levels as alternative payment models are developed and tested.
ACC proposes to scrap ‘inappropriate’ stenting label
The American College of Cardiology proposes to do away with the controversial "inappropriate" label in its guidelines for stenting procedures, replacing it with the rubric "rarely appropriate" and switching the "uncertain" category to "may be appropriate."
The link between obesity and knee replacements in the young
Data gathered by more than 125 orthopedic surgeons from 22 states show that rising rates of obesity among those under the age of 65 are driving the increase in knee replacement procedures.
Medtronic endows EPFK chair in neuro-engineering
Medtronic (NYSE:MDT) said it endowed Switzerland’s Ecole Polytechnique Fédérale Lausanne for an EPFL chair in neuro-engineering. Located in Geneva’s Campus Biotech, the center will be adjacent to research teams at the Human Brain Project, EPFL’s Center for Neuroprosthetics and the new Wyss institute for bio- and neuro-engineering.