Regulatory classes of medical devices

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Reference no: EM133198402

1. For this week's writing assignment, you will be considering supplementary data for 510 (k) submission. Write a one to the two-page essay of a testing report that is typically included in a 510 (k) submission.

2. According to the FDA, how many regulatory classes of medical devices currently exist, and what are the differences between them?

3. What are the usual steps to get a medical device approved by the FDA? At which stages are researchers, manufacturer/sponsor, and FDA involved?

4. After reviewing the FDA's guidance on expedited programs for serious conditions, discuss the pros and cons of priority review and accelerated approval programs.

Reference no: EM133198402

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