US FDA Breakthrough Device (BTD) and Safer Technologies Program (STeP) Designations

Perhaps you have an idea for a medical device that could revolutionize medical care in the US, or perhaps for an improvement that could increase a device's safety or effectiveness. Bringing an innovative device to the U.S. market can present many challenges but also rewards.

The US Food and Drug Administration (FDA) wants to encourage improvements to the overall safety and effectiveness of medical devices, and has developed programs to help companies get their devices to market as quickly as possible: The Breakthrough Device (BTD) and the Safer Technologies Program (STeP) designations. If your device is designated under one of these programs, that opens opportunities for increased collaboration and alignment with FDA regulators prior to the marketing submission, as well as for prioritized review of marketing submissions.

About the presenter

Sarah Marie Fitzgerald, U.S. regulatory program manager and senior RA/QA consultant 

Sarah Marie Fitzgerald leads U.S. regulatory program at Emergo by UL. She has 19 years of experience in medical device regulatory and quality affairs, primarily in the U.S. She has worked with a wide variety of medical devices and other regulated products. Her background covers global regulatory strategy, product support from concept to obsolescence, regulatory premarket submissions, product regulatory due diligence assessments, advertising and promotional support, auditing, and quality management system implementation and improvement and she has worked with BTD and STeP devices. Fitzgerald is a member of the Regulatory Affairs Professional Society (RAPS), maintains a U.S. Regulatory Affairs Certification (RAC), and has a Master of Science in Regulatory Affairs.