Erin Cutts is a senior international policy analyst at FDA’s Center for Devices and Radiological Health (CDRH). While at FDA, she has led various projects related to trade and international harmonization efforts including serving as one of FDA’s representatives on the IMDRF Good Regulatory Review Practices Working Group. She has also managed a variety of Center-wide programs including the Accreditation Scheme for Conformity Assessment (ASCA), which leverages internationally harmonized standards and conformity assessment practices. Erin’s career began as a Research and Development Engineer at a medical device start-up company after which she joined FDA as scientific reviewer and then branch chief in the cardiovascular space. Erin holds a bachelor’s degree in biomedical engineering from Georgia Tech.