Introduction to Medical Device Submissions – 510(k)s, 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.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Byron W. Larson is President of Toltec Inc., a consulting firm specializing in medical-device product development and consulting. He has worked in the medical-device industry for nearly 30 years.

Prior to the formation of Toltec, Mr. Larson was responsible for US Research and Development operations for Gambro Renal Care Products.

Mr. Larson earned his BSME from Colorado State University and his MSME from the University of Colorado. Mr. Larson is certified by the State of Colorado as a Professional Engineer and by the Project Management Institute as a Certified Project Manager.

Mr. Larson is an inventor and co-holder of four United States and two international patents.