medical devices

available through Netflix.

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1. For each device mentioned in the movie, identify:

a. The regulation number and product code

b. The regulatory class

c. The premarket application type

d. The last company that submitted an application, the number of that application and the type of application

2. Identify two regulatory issues that are discussed in the movie that you do not believe are correct. Describe why you do not think it is correct and support your position with the appropriate guidance document or regulatory citations.

3. Identify two regulatory issues that are discussed in the movie that you do believe are correct. Describe why you think it is correct and support your position with the appropriate guidance document or regulatory citations.