Regulatory Center

The Value of Propensity-Matched Registry Data for New Device Evaluation

Novel use of real-world evidence with core lab imaging to create a control group for new medical device evaluation.

By Jack L. Cronenwett, MD; Eleni Whatley, PhD; Misti Malone, PhD; Cassandra Svendsen, BSME, MSBE; Michael J. Kallok, PhD; Kenneth Ouriel, MD; and Jens Eldrup-Jorgensen, MD

Current Landscape for Global Regulatory Acceptance of Real-World Evidence for Medical Devices

Perspectives from the RAPID Global Regulatory Acceptance Group.

By Kenneth Cavanaugh, PhD; Aaron Lottes, PhD; Melanie Raska; Alexia Bwensa; Megan Estes, PhD; Misti Malone, PhD; Rajesh Shah, MD; and Marti Velezis

Regulatory Update: Paclitaxel in 2020 and Beyond

An interview with representatives from the FDA’s Center for Devices and Radiological Health on the current state of paclitaxel-coated device use, including safety, new data, and effects on the peripheral trial landscape.

With Eleni Whatley, PhD; Sara Royce, PhD; and Misti Malone, PhD

Paclitaxel Post-Panel: FDA Discusses What's Next From a Regulatory Perspective

An interview with representatives from the FDA Center for Devices and Radiological Health on the key updates to the letter to health care providers, lessons learned for future trials and follow-up protocols, and additional plans for monitoring in the future.

With Eleni Whatley, PhD, and Andrew Farb, MD

FDA Paclitaxel Safety Panel Preview

An interview with FDA CDRH representatives discussing the upcoming advisory panel meeting to review concerns and current data on paclitaxel-eluting device use.

By Kenneth Cavanaugh, PhD, and Misti Malone, PhD

SPEED: A New Initiative in Real-World PAD Evidence Evaluation

An overview of the FDA's new multistakeholder project to support real-world evidence evaluation for devices aimed at treating peripheral artery disease.

By Misti Malone, PhD

Current Considerations on Real-World Evidence Use in FDA Regulatory Submissions

Examples and decision making from the Center for Devices and Radiological Health's Peripheral Interventional Devices Branch.

By Eleni Whatley and Misti Malone

Registry Assessment of Peripheral Interventional Devices (RAPID)

Developing a minimum core dataset for total product life cycle device evaluation across multiple data sources: a step toward establishing a National Evaluation System for Health Technology for peripheral intervention devices.

By Jose Pablo Morales, MD; Jack Cronenwett, MD; and Robert Thatcher, MBA; on behalf of the RAPID Project Collaborators

Obtaining an IDE for Physician-Modified or Off-Label Stent Grafts

A physician's perspective on applying for an IDE, interaction with the FDA, and practice under an IDE.

With Patrick Kelly, MD

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.

Regulation of Carotid Artery Stents and Embolic Protection Devices in the United States

A history of, and perspectives on, FDA regulation of carotid stents and associated embolic protection devices over the years.

By Sadaf A. Toor, MS; Kenneth J. Cavanaugh Jr, PhD; and Lisa M. Lim, PhD

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

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

Medical Device Labeling

Regulatory terminology associated with device labeling.

By Dorothy B. Abel and Angela C. Smith

Why Are There So Few Vascular Stents Approved?

An interview with Jennifer Goode of the FDA.

By Jennifer Goode

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

Conflicts of Interest

What is their potential impact on device evaluation?

By Dorothy B. Abel

Evaluation of Renal Artery Stenting

Clinical study design, nonclinical testing, and regulatory considerations for appropriate use of this technology.

By Kenneth J. Cavanaugh, Jr, PhD

The Regulatory Perspective

Dorothy B. Abel discusses the FDA's considerations and its role regarding trial data.

By Dorothy B. Abel

Medical Device Reporting

An overview of the current reporting responsibilities.

By Dorothy B. Abel; Angela C. Smith; and Deborah L. Yoder