Article | September 2020
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
News | 09.01.20
CMS Proposed Rule Seeks to Accelerate Coverage and Access for FDA’s Designated Breakthrough Devices
September 1, 2020—The Centers for Medicare & Medicaid Services (CMS) announced it has issued a proposed rule named Medicare Coverage of Innovative Technology (MCIT) (CMS-3372-P), which is intended to allow Medicare beneficiaries to have faster access to the innovative technology.
News | 04.30.20
CMS Issues Second Round of Waivers and Rule Changes During COVID-19 Pandemic
April 30, 2020—The United States Centers for Medicare & Medicaid Services (CMS) announced the issuance of a second round of regulatory waivers and rule changes intended to deliver expanded care to the nation’s seniors and provide flexibility to the health care system during the COVID-19 pandemic.
News | 04.03.20
European Commission Postpones Medical Devices Regulation by 1 Year to Prioritize COVID-19 Response
April 3, 2020—The European Commission (EC) announced the adoption of a proposal to postpone the date of application of the Medical Devices Regulation (MDR) by 1 year to allow European Union (EU) member states, health institutions, and economic operators to prioritize the fight against the coronavirus pandemic.
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 | 06.20.19
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 | 06.19.19
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 | 06.19.19
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 | 04.21.19
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 | 03.14.19
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 | 11.27.18
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.