Comments on: New Minnesota med device group seeks to save 510(k) program http://www.medcitynews.com/2010/01/new-minnesota-med-device-group-seeks-to-save-510k-program/?utm_source=rss&utm_medium=rss&utm_campaign=new-minnesota-med-device-group-seeks-to-save-510k-program MedCity News Sat, 11 Feb 2012 15:17:29 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: John Doe http://www.medcitynews.com/2010/01/new-minnesota-med-device-group-seeks-to-save-510k-program/comment-page-1/#comment-71415 John Doe Mon, 26 Apr 2010 14:14:02 +0000 http://www.medcitynews.com/?p=17982#comment-71415 Can we disconnect the FDA from politics somehow? After years of improvement, the FDA is moving back toward slower and costlier. How exactly does slower and costlier HELP the patients? It doesn't. It helps the payor. And since the Fed gov't will soon be the payor, they want to keep the new, expensive treatments off the market for as long as possible. Can we disconnect the FDA from politics somehow? After years of improvement, the FDA is moving back toward slower and costlier. How exactly does slower and costlier HELP the patients? It doesn’t. It helps the payor. And since the Fed gov’t will soon be the payor, they want to keep the new, expensive treatments off the market for as long as possible.

]]> By: Minnesota med tech community on possible 510(k) overhaul: We’re not gonna take it…. : MedCity News http://www.medcitynews.com/2010/01/new-minnesota-med-device-group-seeks-to-save-510k-program/comment-page-1/#comment-61303 Minnesota med tech community on possible 510(k) overhaul: We’re not gonna take it…. : MedCity News Thu, 18 Feb 2010 16:30:49 +0000 http://www.medcitynews.com/?p=17982#comment-61303 [...] newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food and [...] [...] newly formed Minnesota Medical Device Alliance billed the gathering in the downtown Warehouse District as the first step to help save the Food and [...]

]]> By: Brad Ryba http://www.medcitynews.com/2010/01/new-minnesota-med-device-group-seeks-to-save-510k-program/comment-page-1/#comment-53365 Brad Ryba Wed, 20 Jan 2010 16:28:10 +0000 http://www.medcitynews.com/?p=17982#comment-53365 There absolutely needs to be a change in the 510(k) process...and not in the way of making it more cumbersome. Rather than paint all companies with a broad brush of maligned intent, it would be more accurate to take an exceptions-based approach to the 510(k) review process. The large majority of companies seeking FDA approval are already doing heavy amounts of research, and conducting multistage clinical trials before submitting their products for review. Even in the case of evolutionary innovation, most companies are doing their due diligence, knowing full well that substantial equivalence does not equate to safety and efficacy. These companies should be able to benefit from their upfront investment in their own due diligence, by having the FDA stick to its schedule. Rather, these companies are punished by being grouped with the few that operate with less internal controls. Longer review times does not always equal a higher quality of review. Instead, the inefficient process costs taxpayers millions and delays therapies from getting to public who needs them. There absolutely needs to be a change in the 510(k) process…and not in the way of making it more cumbersome. Rather than paint all companies with a broad brush of maligned intent, it would be more accurate to take an exceptions-based approach to the 510(k) review process. The large majority of companies seeking FDA approval are already doing heavy amounts of research, and conducting multistage clinical trials before submitting their products for review. Even in the case of evolutionary innovation, most companies are doing their due diligence, knowing full well that substantial equivalence does not equate to safety and efficacy. These companies should be able to benefit from their upfront investment in their own due diligence, by having the FDA stick to its schedule. Rather, these companies are punished by being grouped with the few that operate with less internal controls.

Longer review times does not always equal a higher quality of review. Instead, the inefficient process costs taxpayers millions and delays therapies from getting to public who needs them.

]]> By: megphd http://www.medcitynews.com/2010/01/new-minnesota-med-device-group-seeks-to-save-510k-program/comment-page-1/#comment-51808 megphd Thu, 14 Jan 2010 19:22:46 +0000 http://www.medcitynews.com/?p=17982#comment-51808 The 510(k) process is awful, and NOT because the "poor companies" have to do actual research on their products in order to get them approved. It is horrible because if you can reasonably show that your product is "similar" to a product that was previously approved, the FDA has a very difficult task if it is a product that 1) should not have been approved in the first place or 2)is a product that was approved but then recalled or taken off the market. Further, companies try and sneak by products using this method (like a bait and switch). Why device manufacturers feel they should not have to do due diligence and research on the safety of new devices is beyond me. With the new materials (nano particles come to mind) MORE not less research is needed to determine the safety and effectiveness of new devices. The 510(k) process is awful, and NOT because the “poor companies” have to do actual research on their products in order to get them approved. It is horrible because if you can reasonably show that your product is “similar” to a product that was previously approved, the FDA has a very difficult task if it is a product that 1) should not have been approved in the first place or 2)is a product that was approved but then recalled or taken off the market. Further, companies try and sneak by products using this method (like a bait and switch). Why device manufacturers feel they should not have to do due diligence and research on the safety of new devices is beyond me. With the new materials (nano particles come to mind) MORE not less research is needed to determine the safety and effectiveness of new devices.

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