Regulatory Approval of Implantable Medical Devices in the United States and Europe

Abstract

There has been explosive growth in the medical device arena in the last decade with over 9,000 major medical device submissions received by the FDA in 2007 alone. This has affected the timing, approval speed, costs, and strategies used for regulatory approval. Important differences have evolved in the clinical and regulatory environment between the United States and Europe regarding the costs, timeliness, clinical trials, and commercial availability of medical devices. This chapter gives a brief overview of the similarities and differences in the process of obtaining regulatory approval in the United States and Europe.