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Dorothy Abel Joins Syntactx as Vice President, Regulatory Strategy
February 6, 2020—Syntactx announced that Ms.
Medical Device Approval in the US and Abroad
FDA regulation and CE Marking represent different approaches to quality control.
By DOROTHY ABEL
Medical Device User Fee and Modernization Act
How will the MDUFMA have an impact on you, your device, and your industry?
By Dorothy Abel, with Garrett P. Pilcher
Medical Device Reporting
An overview of the current reporting responsibilities.
By Dorothy B. Abel; Angela C. Smith; and Deborah L. Yoder
Inaugural Fogarty Prize Recognizing Medtech Innovations Seeks Nominations
March 17, 2025—Fogarty Innovation and the Linda and Mike Mussallem Foundation announced the call for nominations for the inaugural Thomas J. Fogarty Prize.
Evaluating Thoracic Endovascular Grafts
There has been recent progress in the evaluation of thoracic endovascular grafts—and not just for the treatment of aneurysms.
By Dorothy B. Abel
Standardized Objective Performance Criteria and Control Datasets
How the FDA is working to determine the potential role for these criteria in peripheral device regulation, and how they are best established.
By DOROTHY B. ABEL and ANGELA C. SMITH
Innovation in Regulation Applied to Descending Thoracic Aortic Endografts
FDA Regulatory Review Scientist Dorothy B. Abel discusses what led to the unique expanded approval of a thoracic endograft and a landmark postapproval study.
In Memoriam: Medtech Pioneer Dr. Thomas J. Fogarty, 1934-2025
January 14, 2026—Family, friends, and colleagues are remembering Thomas J. Fogarty, MD, who died at age 91 on December 28, 2025.
FDA Response to Medical Device Regulatory Challenges
A description of initiatives designed to expedite the review process.
By Dorothy B. Abel; Andrew Farb; and Megan Moynahan
Achieving Follow-Up Compliance
Imaging follow-up is integral to assessing device function and aneurysm stability, but patient compliance is challenging.
By Dorothy B. Abel and Angela C. Smith
Cleveland Clinic Stent Summit 2006
Discussions on clinical testing of AAA endovascular grafts.
By Robert G. Whirley, PhD; Matthew S. Waninger, PhD; and Roy K. Greenberg, MD
The Regulatory Perspective
Dorothy B. Abel discusses the FDA's considerations and its role regarding trial data.
The Gore TAG Approval
What took so long?!
Medical Device Labeling
Regulatory terminology associated with device labeling.
Custom Devices
Clarification of the FDA definition of custom devices.
By Dorothy B. Abel, with Harold Pellerite
Conflicts of Interest
What is their potential impact on device evaluation?
Providing a Reasonable Assurance of Safety and Effectiveness
Who is responsible?
FDA Advisory Panels
What exactly are you up against—and why?
By DOROTHY B. ABEL
Exhibit Halls
What exhibitors need to know about the FDA's authority.
