MCCRSCC Medical Device Discussion

I’m working on a health & medical writing question and need an explanation to help me learn.

• Question 1:  In your own words define a combination product.
• This does not mean that you cannot or should not use references to support your definition.
• However, use your own words to define.
• Choose one of the following combination products and determine (and state) the primary mode of action (PMOA).
  • Asthma Inhaler
  • Auto injector insulin pen
  • Lumbar Fusion Device
  • A Coronary Artery drug-eluting stent
• Question 2: 
  • Based on PMOA, is the combination product considered a device or a drug? 
  • Explain why
• Question 3:  FDA center jurisdiction is based on the device’s primary mode of action (PMOA)
  • Based on PMOA which center would have jurisdiction:  CDHR, CDER or CBER
  • Explain why