Global Regulatory and Legal Requirements of Quality.v1
17a Study Guide- Pathway to Medical Device Approval Part 1
1. Which branch of FDA Approves Medical Device products?
2. The Approval Pathway is Based on Device Risk. Fill in the following table:
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Medical Device Risk Classification |
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Classification |
Define |
Examples |
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Class I |
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Class II |
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Class III |
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3. Explain the following:
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FDA Submission Types |
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PMA |
510(k) |
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4. What do you think is meant by “least burdensome” on slide 6, and why is this important (refer to slides 12-13)?
5. Define Predicate (slide 6):
6. Define DeNovo (slide 6):
7. What is a Pre-Sub, and why is this beneficial for companies?
8. On slide 11, a 510(k) is to request ________________ for your product to be on the market, whereas a Pre-Market Approval application is to request approval.
9. Explain Substantial Equivalence