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<p>[QUOTE="anonymous, post: 6097003"]There are two avenues for FDA approval, PMA and 510k:</p><p><br /></p><p>PMA is the most stringent regulatory category and must contain sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. </p><p><br /></p><p>A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device and is not subject to premarket approval.</p><p><br /></p><p>Knock-off products are almost exclusively 510k approvals, and thus take the less stringent path to market.</p><p><br /></p><p>The fact of the matter is that a single complication arising from a failed staple line will likely cost the hospital more (in re-admitting cost and liability payments) than they are saving by purchasing aftermarket reloads. Some will be willing to roll the dice, but I suspect that most will not.[/QUOTE]</p><p><br /></p>
[QUOTE="anonymous, post: 6097003"]There are two avenues for FDA approval, PMA and 510k: PMA is the most stringent regulatory category and must contain sufficient valid scientific evidence to assure that the device is safe and effective for its intended use. A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device and is not subject to premarket approval. Knock-off products are almost exclusively 510k approvals, and thus take the less stringent path to market. The fact of the matter is that a single complication arising from a failed staple line will likely cost the hospital more (in re-admitting cost and liability payments) than they are saving by purchasing aftermarket reloads. Some will be willing to roll the dice, but I suspect that most will not.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Covidien
>
AEON Stapler
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
Covidien
>
AEON Stapler
>