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Course 3636
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Which costly, time-consuming studies are always needed for products requiring a Premarket Approval, AND what is the purpose of these studies?
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If your drug eluting stent is the first drug eluting stent on the market, which medical device filing to the FDA would be required in order for you to start selling your product: A) 510(k) for product clearance or B) Premarket Approval Application (PMA)? Clearly state your choice of A) or B) and explain why.
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An entrapment area is a risk because (select all that apply):
100%
100%
0%
100%
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Provide 2 examples of contamination (other than "dirt" or "dust") that could be present on equipment surfaces that would need to be studied for proper removal during cleaning validation.
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Using the figure included in this question as a visual aid for the blending operation, list 2 blending operation variables you would want to study during validation in order to reduce the impact to content uniformity (think about the example given during the review session about mixing dry ingredients for cupcakes).
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