Regulatory Approval of Implantable Medical Devices in the United States and Europe
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.
KeywordsMedical Device Regulatory Approval Competent Authority Pivotal Trial Investigational Device Exemption
- 1.Chai JY. Medical device regulation in the United States and the European Union: a comparative study. Food and Drug Law Journal, 55: 57–80 (2000).Google Scholar
- 2.21 USC §360.Google Scholar
- 3.21 USC § 360(c).Google Scholar
- 4.Medical Device Amendments of 1976, Pub L No 94-295 (1976).Google Scholar
- 5.Food and Drug Administration Modernization Act of 1997, Pub L No 105–115 (1997).Google Scholar
- 6.21 CFR 56 (2003).Google Scholar
- 7.US Food and Drug Administration web site. Available at: http://www.fda.gov.
- 8.Council Directive 98/97/European Economic Community. Annex I.A. 3–5; O.J. (L331) 15.6. Page 8 GAO-05-1042 FDA‘s Review of Device Applications, (1998).Google Scholar