Project #21224 - classifing a medical device

Please write a 3 pages essay (1.5 line spacing) on how you would go about determing the classification of a medical product that is described in the following paragraph.  Be sure to identify the critical information you need from the company developing the product, assumptions you are making, regulation and guidance documents you would/are following and what interactions you might have with the FDA to confirm your classification.

 

The Regain implant is a permanent spinal implant that is inserted within the spinal disc.  It does not mechanically support the spine but occupies space and interacts with the natural disc material and encourages the rehydration of the disc (disc dehydration as one gets older is a common degenerative process that can result in pain).  The company does not claim on their labeling that the implant material has any special chemical compounds/materials that interact with the human physiology.  However, in the material description that must be supplied to FDA during premarket review, several compounds are impregnated within the implant substrate material that are hydrophobic and can be resorbed into the surrounding extracellular fluid.

Subject Medicine
Due By (Pacific Time) 01/22/2014 08:00 pm
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