What steps does FDA take to determine compliance with the GMP requirements? a. R

Question

What steps does FDA take to determine compliance with the GMP requirements? a. Reports provided by patients b. Inspection of operations c. Inspection of records d. All of the above e. b) and c) only Safety and Effectiveness determination by FDA needs to be based on: a. Valid scientific evidence b. Testimonials of medical device sales staff showing customer satisfaction. c. All of the above FDA's device classification is a. Duration of intended use b. Risk-based c. Cost-based What is FDA's Statutory Mission? a. Approve Safe and Effective Devices and Pharmaceuticals b. Promote and Protect the Public Health c. None of the above

Explanation / Answer

8.

d. All of the above

these all three step does FDA take to determine compliance with the GMP requirements.

9.

A. Valid Scientific evidence

10.

b. Risk based

11.

b. FDA statutary mission oromote and protect public health

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