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The Regulatory Perspective
Dorothy B. Abel discusses the FDA's considerations and its role regarding trial data.
By Dorothy B. Abel
The Gore TAG Approval
What took so long?!
Medical Device Labeling
Regulatory terminology associated with device labeling.
By Dorothy B. Abel and Angela C. Smith
Medical Device Reporting
An overview of the current reporting responsibilities.
By Dorothy B. Abel; Angela C. Smith; and Deborah L. Yoder
Custom Devices
Clarification of the FDA definition of custom devices.
By Dorothy B. Abel, with Harold Pellerite
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.
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.
CAS Approval and Reimbursement
Let's not forget about the individual patient.
By DOROTHY B. ABEL, with ANGELA C. SMITH AND KENNETH J. CAVANAUGH
Investigational Device Exemptions
When should investigators use this route to study a new device?
Regulation of Peripheral Vascular Devices
Current issues in the regulation of IVC filters.
By Angela C. Smith and Dorothy B. Abel
Expanded Access
What you need to know about compassionate and emergency uses of investigational and unapproved devices.
Off-Label Medical Device Use
Our FDA expert provides answers to questions about a serious, if common, situation.
Crime and Punishment
Are you aware of your responsibilities in complying with the rules and laws of the FDA?
FDA Insights: Top 10 Issues and Insights for Endovascular Grafts
Perspectives on the current state of endovascular grafting technology.
Current issues in the regulation of SFA stents.
By David S. Buckles; Jennifer L. Goode; and Dorothy B. Abel
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.
