FDA Reclassifies Surgical Staplers and Staples

The FDA has reclassified surgical staplers and staples from Class I to Class II devices, requiring them to undergo premarket review. Since they have been reclassified, these devices will now be subject to more stringent regulatory requirements, such as premarket notifications and special controls to help mitigate known risks of these types of devices. But what does this really mean regarding evaluation of biocompatibility for surgical staples?

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