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Report calls for blowing up key path for product approvals.
The IOM conclusions are not supported by data anywhere close to the radical change that would occur by the elimination of the 510k process. While there is always a need to consider changes that would lead to improved patient safety, the additional cost of a process closer to an IDE would have a very high hurdle to improve on the existing 510k procedure.
The 510K application should include a statement that the device and procedure will result in a reduced cost/price. Only 510K approved devices that cost less should be approved.
FDA is not legally allowed to consider price, cost savings, or cost effectiveness when reviewing device applications. That is reserved for CMS in the next phase of review for Medicare coverage and payment.
I had to laugh at this one. The Star Tribune is in bed with the Institute of Medicine on everything from what should be covered under Obamacare to the mandate that free birth control be provided under insurance plans. Obviously the STrib (and our illustrious senatorial contingent) opposes the IOMs opinion on standards for medical devices simply because many medical device companies happen to be located in Minnesota. This editorial implicitly concedes that the control of health care by the Federal Government will devolve into just another exercise in interest group politics. Thanks for the concession STrib: it's what opponents of Obamacare have known all along.
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