Introduction to Medical Device Submissions - 510ks, PMAs, and Exemptions

This course covers current FDA regulatory compliance with respect to developing and marketing medical devices.  A focus will be placed on relevant aspects of FDA regulations and

the practical aspects of bringing a medical product to market.

The course will initially cover the general context for medical device regulations. Later, a more in-depth discussion will begin to look at each of the submission categories in detail. 

FDA’s regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course.