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What you must teach the FDA...

Technology changes so fast, the FDA cannot possibly be current with all the new inventions. This is a problem for the FDA. The reviewers can attend seminars but still they are not conversant in all the new medical device applications.

The FDA looks to industry (you) to teach the reviewers the appropriate technologies that the FDA must approve. You must be prepared to teach them as part of your submission.

The FDA cannot create guidance documents on every new medical device. New medical devices occur so quickly! Often the technology is used in such small numbers in specialized functions that control becomes as difficult as it now is.

copyright by Compliance Consultants, Stamford, CT USA, September 2001