If a company were to somehow successfully figure out a method of developing artificial organs for use by patients in need of immediate transplant then I would definitely agree that it would classify as a Class III device. Any devices that support or sustain human life, that are of substantial importance in preventing impairment of human health, or which present potential, unreasonable risk of illness or injury is without a doubt a Class III medical device according to the FDA. Ultimately, the end goal of this pathway is to obtain a PMA. From the Week 2 Lecture of Regulations the company must first submit an RFD. The FDA will determine if this product is a device, drug, or biologic.

I’m not sure if I’m misclassifying the product, but this example I feel could be a combination of a device and a biologic. The reason I think it could be a biologic is because it is essentially an artificial organ made up of tissues that’s entering the blood stream. However, if this were to continue and be classified as a Device, then it would still be regulated by the CDRH.

After its RFD, the company could needs to have clearance for an IDE. An IDE for whats needed to run clinical trials. Usually before this, a company proposes a Pre-IDE that is compiled with animal research or in-vitro research that proves the device is indeed safe.