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.