Catholic University of America The Bleeding Edge Documentary Discussion

  1. For five devices that are mentioned in the movie (you choose the five), identify:
    1. The regulation number and product code
    2. The regulatory class
    3. The premarket application type
    4. 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 in detail 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 in detail why you think it is correct and support your position with the appropriate guidance document or regulatory citations.
  4. Should all devices be regulated through the premarket approval application pathway?
  5. For the Essure device , briefly summarize the information that was included in the premarket submission.Identify what additional information, if any, that you believe should be included in the premarket submission.If you feel that no additional information is necessary, please explain why?

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