Fundamentals of US FDA Medical Device Submission Process

The medical device market is one of the world's most highly regularized and stringently controlled. Whether it is manufacturing, marketing, or testing of medical devices, all the processes are subjected to multaiple regulations and laws. Different bodies and institutions around the world enact these laws and regulations. The US FDA (Food and Drug Administration) is one such agency. As a federal agency of the USA, it is responsible for making laws and regulations governing the manufacturing and marketing of these devices.

The course developers at Exoexcellence Consultants have high expertise in the medical device market, especially those in the EU and the US. With this course, they have tried to provide a basic orientation to medical device marketing in the USA. The target audience of this course is medical device manufacturers and regulatory experts in this field. With this unimodular course, they can build their foundations in medical device marketing in the USA. Even if they are veterans in this field, this course will help them revise their basics.

The structure of this course is pretty simple. There are only three topics. These topics discuss the steps involved in medical device marketing in the USA, the marketing pathways for medical devices described by the FDA, and a comparison between ISO 13485 and 12 CFR Part 820. Both are the basic standards requiring medical device manufacturers to establish a QMS. Overall, this course is a helpful resource for anyone looking to penetrate the medical device market of the USA.