Question: When making changes after the product is on the market, potential risk is used to determine whether FDA approval is needed. A CBE - 3

When making changes after the product is on the market, potential risk is used to determine whether FDA approval is needed. A CBE-30 filing can be used for changes that are not high risk. Fill-in the following 2 blanks:
If after submitting a CBE-30 to the FDA for changes to a product or process, a company has not heard any concerns from the FDA after ___A___ days, then the company is allowed to____B_____
A =_____________
B =_____________

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