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Class 1 Devices by Peter J Ogrodnik

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Chapter 2

Classification

Abstract

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.

Keywords

classification
class
cutters
FDA
MDD

2.1. Introduction

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. ...

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