Monday, June 18, 2007

Complex biomedical devices

cool.click
cool.click™ is a needle-free device that delivers Saizen® through the skin The drug is delivered subcutaneously and provides the equivalent biological dose of Saizen® as do needle injections. Because it is needle-free, cool.click™ reduces pain and anxiety for patients that are undergoing daily treatment for Growth Hormone Deficiency. Looking at this product, in which group would you place it: is it a medical device or pharmaceutical product?




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2 comments:

Unknown said...

It is a combination product and should be addressed by the office of combination products that will designate the key stakeholder in the approval process.

Anonymous said...

why nobody leaves you a comment ?