Dorothy Abel

Dorothy retired from the FDA after 30 years, with the majority of her career serving as the FDA expert on vascular and endovascular prostheses.  During that time, she introduced innovative approaches for the clinical evaluation of devices through extensive collaboration with industry and clinicians, co-founded the Early Feasibility Program, and trained FDA staff on least burdensome principles.  Dorothy participated in the White House Entrepreneurs in Residence program and was frequently an invited author and speaker, including co-authoring an article on early feasibility studies with Dr. Rob Califf (FDA Commissioner at the time), and other clinicians, including Drs. Zuckerman, Farb, and Holmes.  She led the international development of standards for endovascular grafts, vascular stents, vascular grafts, and vena cava filters.  She authored the FDA guidance for vascular grafts, including the clinical evaluation of vascular access grafts, which served as the foundation for the subsequent requirements in the ISO standard.  Dorothy was the lead reviewer on all endovascular grafts initially, the first TIPS covered stent IDE and PMA, and the first venous valves, in addition to other innovative vascular devices.  She was the active branch chief responsible for the first carotid stent approval.  Dorothy hosted two FDA workshops on the testing of endovascular grafts before teaming up with Dr. Roy Greenberg on organizing and facilitating the Stent Summit which brings together clinicians, manufacturers, regulators and others to collaboratively discuss and propose approaches for improving endovascular graft designs and evaluation.

 While at FDA, Dorothy’s honors included becoming an AIMBE fellow, receiving the FDA Civil Service Engineer of the Year award, being invited as the keynote speaker for the Australasian College of Surgeons meeting, receiving special recognition from AAMI, and being invited to present grand rounds for the University of Pennsylvania Department of Surgery, as well as receiving multiple additional awards from within FDA.  After retiring from the FDA, Dorothy received the CDRH Career Achievement Award, was invited to give grand rounds for the University of Washington Department of Surgery, and was invited to present the keynote address at the Critical Issues America meeting.  Dorothy continues to be an invited participant in meetings (e.g., VEITH Symposium, CRT, CVID) and collaborative efforts such as the ARCH-ARC initiative to standardize nomenclature associated with the treatment of lesions in the ascending aorta, aortic arch, and descending aorta.  She also continues with her support in orchestrating the Greenberg Stent Summit.