News | 02.26.20
FDA's eSTAR Program Seeks to Promote Greater Efficiency and Consistency in the 510(k) Process
February 26, 2020—The FDA announced the launch of eSTAR, a voluntary electronic submission template and resource pilot program as an alternate method available for selected industry participants in the pilot to prepare a 510(k) submission.
News | 01.22.20
United States and Japanese Stakeholders Discuss Cardiovascular Device Harmonization Activities at HBD Think Tank
January 22, 2020—On December 11, 2019, physicians, regulators, and industry members from the United States and Japan participated in the 2019 Harmonization By Doing (HBD) Think Tank in Tokyo, Japan. Since its initiation in 2003, the HBD collaboration has strived to promote United States–Japanese regulatory and clinical convergence by developing and piloting innovative and practical approaches to addressing shared real-world challenges affecting the evaluation and availability of cardiovascular devices in both countries. Lessons learned from these activities have been actively communicated to the cardiovascular community through publications, discussions at scientific symposia, and dedicated Think Tank workshops.
News | 01.13.20
FDA Issues Draft Guidance on 510(k) Submission for Peripheral PTA Catheters
January 13, 2020—The FDA Center for Devices and Radiological Health has issued a draft guidance regarding 510(k) premarket notification submissions for peripheral percutaneous transluminal angioplasty (PTA) and specialty catheters.
Article | September 2019
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
News | 06.21.19
CDRH Provides Statement on Efforts to Increase Transparency in Medical Device Reporting
June 21, 2019—The FDA Center for Devices and Radiological Health (CDRH) issued a statement from Director Jeffrey E. Shuren, MD, announcing the steps being taken to update the CDRH Medical Device Reporting (MDR) Program and promote public transparency. The FDA uses the MDR to monitor device performance, detect potential device-related safety concerns or signals, and contribute to the benefit-risk assessment of these products.
News | 06.20.19
FDA Paclitaxel Advisory Meeting Day 1: Panel Addresses Updated Data, Signal Presence, Class Effect, Missing Data, Subgroups, and Causes of Death
June 19, 2019—Among efforts to explore and address concerns raised by recent meta-analysis data that found an increased mortality signal in patients treated with lower extremity paclitaxel delivery devices, the US Food & Drug Administration convened an advisory committee to be held June 19–20, 2019, in Gaithersburg, Maryland.
News | 06.20.19
FDA Advisory Meeting Day 2: Panel Weighs the Future of Paclitaxel and Clinical Trials in PAD
June 20, 2019—After a full first day of presentations, questions, deliberations, and recommendations, US FDA advisors reconvened to address additional queries posed by the agency as to the safety and efficacy of paclitaxel therapies in peripheral artery disease (PAD), as well as future steps needed to ensure and communicate their status.
News | 04.22.19
FDA Schedules Public Meeting on Paclitaxel Use in PAD
April 22, 2019—The FDA announced that the Circulatory System Devices Panel of the Medical Devices Advisory Committee will convene a public meeting to discuss and make recommendations on information related to recent observations of increased long-term mortality in patients with peripheral arterial disease treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared with patients treated with uncoated comparator devices.
News | 03.15.19
FDA to Convene Advisory Committee Meeting After Preliminary Review Finds Signal of Increased Mortality With Paclitaxel-Eluting Devices
March 15, 2019—The FDA has announced that its preliminary review of the long-term follow-up data on paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral artery disease (PAD) in the femoropopliteal artery has identified a potentially concerning signal of increased long-term mortality in study patients treated with paclitaxel-coated products compared to patients treated with uncoated devices.
News | 11.28.18
FDA Announces Plans to Modernize 510(k) Program
November 26, 2018—FDA Commissioner Scott Gottlieb, MD, and Jeff Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH), announced proposed changes intended to modernize the 510(k) clearance pathway to keep pace with the increasing complexity of rapidly evolving technology.
News | 06.19.18
FDA Issues Update Regarding Type III Endoleak Risks
June 19, 2018—The US Food and Drug Administration (FDA) announced an update to its 2017 advisory regarding the risks associated with type IIIa and IIIb endoleaks with various aortic endovascular graft systems indicated for endovascular aneurysm repair (EVAR) procedures in the treatment of abdominal aortic aneurysms (AAAs) and aortoiliac aneurysms.
News | 05.08.18
FDA Issues Recommendations on Neurovascular Stents Used for Stent-Assisted Coiling of Unruptured Brain Aneurysms
May 8, 2018—The US Food and Drug Administration (FDA) has issued a letter to health care providers providing recommendations on patient selection and device use of neurovascular stents for stent-assisted coiling (SAC) of brain aneurysms.
News | 01.19.18
FDA Seeks to Strengthen Public Warnings and Recall Notifications; CDRH Outlines Strategic Priorities
January 18, 2018—US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, issued a statement on the agency's new policy steps for strengthening public warnings and notifications of recalls.
News | 03.01.17
FDA Letter Warns About Off-Label Use of Neurovascular Guide Catheters for Thrombus Removal
March 1, 2017—The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) issued a letter to health care providers regarding the differences in the FDA review and the intended use of neurovascular thrombus retrieval catheters and guide catheters (eg, intermediate catheters, distal access catheters) for neurological interventional procedures.
News | 08.24.16
FDA and Industry Groups Announce Tentative Accord to Reauthorize Medical Device User Fee Agreement
August 24, 2016—The US Food and Drug Administration (FDA) announced that it has reached an agreement in principle with representatives from the medical device industry and laboratory community on proposed recommendations for the fourth reauthorization of a medical device user fee program.
Article | August 2016
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