Page 42 - Biomedical Engineering and Design Handbook Volume 2, Applications

CHAPTER 2

FDA MEDICAL DEVICE

REQUIREMENTS

Robert Klepinski
Fredrikson & Byron, PA, Minneapolis, Minnesota

2.1 INTRODUCTION 21 2.11 MARKETING CLEARANCE OF
2.2 WHAT IS A MEDICAL DEVICE? 21 COMBINATION PRODUCTS 34
2.3 WHAT IS FDA? 22 2.12 TESTING MEDICAL DEVICES ON
2.4 STATUTE AND REGULATIONS 23 NONHUMAN ANIMALS AND
2.5 WORKING WITH FDA 25 LIFE FORMS 35
2.6 SCOPE OF REGULATION 25 2.13 TESTING MEDICAL DEVICES ON
2.7 MARKETING CLEARANCE OF MEDICAL HUMAN SUBJECTS 36
DEVICES 25 2.14 QUALITY SYSTEM
2.8 PREMARKET APPROVAL (PMA) 28 REGULATION 42
2.9 PREMARKET NOTIFICATION 2.15 MEDICAL DEVICE
[PMN OR 510(k)] 31 REPORTING 55
2.10 COMPARISON TO EU
REGULATION 33

2.1 INTRODUCTION

Engineers will find that working with medical devices is a different experience from dealing with
other projects. While many areas of engineering involve extensive regulation, such as in nuclear
products, it is difficult to imagine an area with more pervasive government control than the design,
production, and sale of medical products. Regulation is simply inherent in the medical area, and it
is a necessary part of engineering practice to be aware of the complexities and nuances of working
in this environment.
While the primary focus of this chapter is on medical devices, engineers may now be exposed
to many other types of regulation. The current trends toward combining technologies will bring
engineers into contact with products that include combinations of drugs, biologics, and medical
devices.
This chapter discusses the cradle-to-grave nature of U.S. medical device regulations, as well as
a look at the comparable European Union (EU) regulatory scheme.

2.2 WHAT IS A MEDICAL DEVICE?

The term medical device covers an extremely broad range of products. Medical devices range
from the simplest over-the-counter health aids to complex implantable life-supporting devices.

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