Bill Walton might be the medical device industry’s best customer.
The 59-year-old former NBA player and basketball legend has had 36 orthopedic procedures, starting with his first surgery at 13 years old.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Bill Walton might be the medical device industry’s best customer.
The 59-year-old former NBA player and basketball legend has had 36 orthopedic procedures, starting with his first surgery at 13 years old.
As the medical device industry creeps ever nearer the launch date for the dreaded medical device, stakeholders and advocates seem to be picking up their efforts to lobby for repeal.
Industry groups this month issued comments on an IRS draft tax code, alternatively calling for repeal and for mercy, while a pair of Pennsylvania legislators spent some time discussing the potential impacts with local device makers.
For 2 years the medical device tax has been billed as the $20 billion price tag the med-tech industry must pay to cover its share of health care reform.
The 3rd iteration of the FDA’s medical device user fee program rolls ever closer to finalization, as the watchdog agency and industry players move forward with a draft of the legislative language.
In a back-to-back series of 5 meetings in the first half of February, the FDA and med-tech leaders closed up some exceptions to the requirements of the Medical Device User Fee & Modernization Act, hashed out a new structure for inflation adjustments and reconciled a discretionary fee waiver for laboratory-developed tests.
Medical device makers and industry lobbyists lined up in support of the tentative agreement inked with the FDA to double user fees in exchange for performance goals, but some voices in the crowd said ‘nay.’
The Institute of Medicine’s report on the FDA’s 510(k) clearance process for medical devices falls so far out of the scope of the questions it was meant to answer that it’s essentially meaningless, med-tech industry reps told the agency during negotiations over re-authorizing the Medical Device User Fee & Modernization Act.
The Centers for Medicare & Medicaid Services introduced a proposal to change the way hospitals are paid as part of President Barack Obama’s landmark health care reform law.
The proposal includes guidelines for so-called "accountable care organizations," designed to help rein in unchecked health care costs by restructuring the fee-for-services system hospitals currently use.
The Food & Drug Administration’s user fee program collects payments from medical device makers when they submit their devices for review by the federal watchdog agency. Yesterday, MassDevice took a look at competing claims from the medical device industry, the FDA and other stakeholders over the effectiveness of the program. Today we look deeper into whether the program is adequately meeting its own goals.
Another commitment the FDA made in exchange for receiving user fees from industry was to expedite its production of guidance documents to provide industry with a "roadmap" of how to bring a product from development to clearance for sale.
It takes 20 percent longer to obtain a final decision on a 510(k) submission than it did in 2002, despite the millions the Food & Drug Administration has collected from medical device makers in so-called "user fees," according to AdvaMed’s Janet Trunzo.
Trunzo, AdvaMed’s executive vice president for technology and regulatory affairs, was one of several industry association speakers who expressed disappointment in the medical device user fee program at a Sept. 14 workshop held to gain stakeholder input on the program.
"Our companies are concerned that the link between performance and fees has broken down," said Medical Imaging and Technology Alliance executive director David Fisher.