Who Should Attend

This course will be most valuable to medical device/product professionals who need an understanding of how to get medical devices into the US market while respecting FDA regulations.  The course is geared toward professionals that are newer to the industry or who need to gain an understanding of submissions for the first time. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of medical device submissions will benefit from this course. 

Learning Objectives

Upon completion of this course, attendees will have an understanding of the framework for FDA submission regulations and an approach on how to construct a submission. An appropriate submission strategy is necessary to legally manufacture a product in the US market.  The course focuses on how a company’s product situation needs to be evaluated in order to determine the correct interpretation of the submission requirements.  Emphasis will be placed not only on regulatory aspects, but on the overall medical device product development strategy and environment.  Creating an effective submission strategy will help your company avoid spending unnecessary time and money by avoiding an inappropriate path.

Exercises and presentations from the FDA will be used to reinforce the key concepts from the course presentation.  Attendees will receive extensive course notes that can be used as reference material once the course is completed.

Course Description

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.

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