This SPARK Studio session will provide a high-level overview of the U.S. FDA regulatory framework for medical devices, focusing on key requirements for manufacturers. Topics will cover FDA classification system (Class I, II and III), product code selection and premarket pathways (i.e. 510(k), PMA, De Novo).

Attendees will gain insights into the submission process, predicate device selection, and ongoing compliance obligations under FDA guidelines. 

Alexandra Schardt, Manager, Regulatory Affairs for MCRA will be hosting this talk. Alexandra has over 7 years of experience in the biotechnology industry and medical device regulatory affairs. She is also RAC-certified in medical device regulatory affairs. 

See the full agenda and register for free below.