Home » FDA Proposes Rule to Make Tissue Expanders Class II Devices
FDA Proposes Rule to Make Tissue Expanders Class II Devices
Before submitting a 510(k), the FDA recommends manufacturers of tissue expanders conduct an analysis to identify additional risks associated with their devices. The FDA simultaneously issued a proposed rule and a draft guidance to classify tissue expanders as Class II special controls devices last month.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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