This chapter examines the classification of Class I and 510(k) exempt devices. Case studies are used to demonstrate the process. The reader is given the opportunity to undertake classifications for themselves.
In this chapter, we will be using the case studies to examine how a classification is discerned. In all of these cases, there is a precedent on which to make a judgement. This text is not considering those devices for which there has never been anything like it before (consider the first ever X-ray machine). In nearly every medical device case study I have been involved with, there has been a precedent on which to base a judgement. ...
With Safari, you learn the way you learn best. Get unlimited access to videos, live online training,
learning paths, books, interactive tutorials, and more.