WASHINGTON (CN) – The Food and Drug Administration plans to reclassify a medical stomach pump as a device that no longer needs pre-market approval for the treatment of poisoning and drug overdose, according to a new FDA rule.
Instead, the device, or sorbent hemoperfusion system, would require “special controls,” which are meant to ensure safety and effectiveness.
Although approval is not required, makers of the device still would need to send pre-market notification to the FDA.
The FDA also plans to require the filing of a premarket approval application or a notice of completion of a product development protocol when the device is for the treatment of hepatic coma and metabolic disturbances.
The FDA has proposed these “special controls” for the treatment of poisoning and drug overdose with the sorbent hemoperfusion system: the device should be demonstrated to be biocompatible; performance data should demonstrate the mechanical integrity, sterility and shelf life of the device; bench performance data should demonstrate device functionality; there should be a summary of clinical experience with the device; there should be labeling controls, including appropriate warnings, precautions, cautions, and contraindications statements; and for those devices that incorporate electrical components, there should be appropriate analysis and testing to validate electrical safety and electromagnetic compatibility.
Click the document icon for this regulation and others.