8: Medical Device and Combination Products
- Page ID
- 39525
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Objectives
- Understand how the FDA classifies a medical device
- Describe how FDA regulates approvals: PMN, PMA, IDE, and IRB
- Understand regulations that govern medical devices
- Explore and apply CFR 82
- Differentiate between Class I, II, & III medical devices
- Distinguish between IVD, IUO, RUO, LTD, GPR, & ASR
- Understand ISO 13485 and why it is important in device regulation even though it is regulated by the FDA through CFR 820
- Provide examples of combination products