Prior to joining NAMSA through the acquisition of Syntactx, Dorothy Abel had a highly accomplished 30+ year career with the U.S. Food and Drug Administration (FDA) within the Center for Devices and Radiological Health (CDRH). At the FDA, Dorothy led the evaluation of vascular and endovascular surgery devices, and pioneered approaches for the evaluation of devices, including co-founding the Early Feasibility Study Program in collaboration with FDA colleagues, of professional surgical societies and international voluntary standards committees. Ms. Abel provides expert assistance in developing and communicating regulatory evaluation strategies and helps Clients achieve regulatory approvals and product adoption worldwide.

 CORE COMPETENCIES

• Identifies options for clinical evaluation of new and modified devices
• Interprets FDA feedback and suggests approaches for responding
• Optimizes communication and maps out successful interactions with the FDA
• Provides regulatory support throughout the product lifecycle, from non-clinical evaluation planning through post-market evaluation
• Assists in major submission preparation, including writing and reviewing regulatory documents (e.g., breakthrough technology designation requests, pre-submissions, IDEs, PMAs)
• Facilitates FDA meeting preparation, attendance and follow-up

RECENT PROJECTS

• Creating vital responses for Sponsors as a result of FDA feedback
• Developing clinical evaluation strategies for novel technologies