Training And Education Of Regulatory Requirements To Increase The Effectiveness Of Technology Introduction

Thank you for inviting me to discuss with you today about issues that are so pertinent to us all, the impact of governmental regulations on health care technology. Our particular workshop put emphasis on how the training and education can increase the effectiveness of technology introduction. It is a necessity to know and to understand (the regulatory processes), the scientific requirements and how to introduce medical devices into the U.S. market. Let me relate Food and Drug Administration's (FDA's) regulations by addressing the 6 Ws - why, when, what, which, who and where. Why are governmental regulations needed? FDA has to carry out its mission. It is working to protect and promote the health of the American people, When should one be concerned about the governmental regulations? Before designing a medical device, it is important to know what are the regulatory processes and scientific requirements criteria that FDA is training and educating their scientific reviewers to look for in a medical device. What are some scientific criteria to ensure safety and effectiveness of a medical device for its intended use? One considers design and design validations, components reliability testings, quality assurance and quality control testings for method of manufacturing and other general criteria.