Introduction to CFRs 800 & 820 for Medical Devices – 2020

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cfrs fda

This interactive e-Learning course provides a straightforward introduction to both the US FDA and the Code of Federal Regulations (CFRs). This course explains:

  • the role of the US FDA including how changing technology impacts regulations
  • how the US FDA may interact with your site including audit tips and warning letters
  • how different the regulations (e.g. finished product, medical devices and biologics) are structured within the CFRs