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bb254 replied to the topic Meat without Murder in the forum Introduction to Project Management 8 years, 4 months ago
If this method of murderless meat is viewed highly enough to raise the claim of developing artificial organs which would be used for patients that needed transplants,then by FDA regulations it is a class 3.According to our lecture this week, a class 3 is marketed as a high risk device. Any high risk device requires Pre-market Approval and clinical trials. Since the contrivance implant requires clinical trials the IDE document needs to be filled out to explain what the trails would consist of and why they need to be executed. Within these trials the organ implant needs to validate that the device is safe and The PMA document needs to be completed because these implants are life supporting devices which are novel. The device will then have to be seen by a panel of experts commissioned by the FDA to determine if it is recommended for approval.
As an example of an artificial organ,the link below gives details on an artificial pancreas and the clinical data required to get the approval of the FDA.
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/homehealthandconsumer/consumerproducts/artificialpancreas/default.htm