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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
Regulation of Peripheral Vascular Devices
Current issues in the regulation of IVC filters.
By Angela C. Smith and Dorothy B. Abel
Providing a Reasonable Assurance of Safety and Effectiveness
Who is responsible?
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
Achieving Follow-Up Compliance
Imaging follow-up is integral to assessing device function and aneurysm stability, but patient compliance is challenging.
The Preclinical Testing of Endovascular Grafts
How the FDA, physicians, and industry are working together to develop new testing and performance standards.
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
Live Cases Involving Investigational Devices
With the popularity of live-case demonstrations continuing to grow, the FDA is aiming to make sure they are conducted in adherence with safety and regulatory guidelines.
Much Anticipation for 2005
By Barry T. Katzen, MD Chief Medical Editor
Treating DVT
Focus on Vascular Imaging
By Takao Ohki, MD, PhD, Chief Medical Editor
Stroke Management
By John R. Laird, Jr, MD, Chief Medical Editor
