Wisconsin MPJE (Pharmacy Jurisprudence) Practice Exam

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The Medical Device Amendment of 1976 included which main requirement?

  1. ANDA for medical devices

  2. Guidelines for drug labeling

  3. Requirements for devices

  4. Distinguishing between Rx and OTC devices

The correct answer is: ANDA for medical devices

The correct answer is A. The Medical Device Amendment of 1976 required manufacturers of medical devices to submit an Abbreviated New Drug Application (ANDA) for their devices, similar to the requirement for generic drugs. This allowed for the approval of generic versions of medical devices, ensuring safety and effectiveness while promoting competition in the market. Options B, C, and D are not directly related to the main requirement of the Medical Device Amendment of 1976. The amendment focused on regulatory requirements specific to medical devices, ensuring their safety and efficacy for the public.

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