Kidney Health Initiative (KHI)

KHI Current Project

Regulatory Policies and Positions Affecting Device Approval in the US: Tools to Assess the Process and Foster Device Development for Patients with Kidney Disease

Patient Care Issue:

There have been few innovative therapies marketed for patients with chronic kidney disease (CKD) or end stage kidney disease (ESKD) during the last decade. In addition, many innovative therapies are marketed in Europe and Canada years earlier than in the United States.

Challenge:

For medical device development, it is essential that device manufacturers and other stakeholders have optimal information regarding the standards and requirements for approval of clinical trial protocols and market approval for devices at FDA.

KHI Solution:

KHI assembled a workgroup that has defined and is studying a few broad categories of devices that have been marketed outside of the United States. The workgroup is determining the value of these devices in patient care, ascertain pathways to expedite approvals in the United States (if felt to be appropriate), and then summarize their findings in a white paper.

Status:

The workgroup has selected to focus on central venous catheters and hemodiafiltration systems. Both groups have drafted their manuscripts, which are currently in FDA review and clearance.

Proposed White Paper Outline:

  1. Outline the unmet health need that the device is intended to provide, to include but not limited to:
    • a general description of the device category
    • how the device provides a therapeutic option that is not currently available
  2. Identify common issues (“deficiencies”) raised during prior review processes. Anonymity of all prior submissions will be honored. An example of an “issue” would be biocompatibility test requirements for a 510(k) submission. For each major issue,
    • cite the standard or reason provided by the FDA for the requested information
    • identify the difficulties/barriers for sponsors/investigators to satisfactorily fulfill the request
  3. Identify issues that should be considered in assessing the benefit and risk for the device category, including patient preferences, for the intended use population.
  4. Identify recent technological advances that should require special consideration by the FDA in future study/marketing applications, and determine if the technologic changes will require unique types of testing and/or considerations for change/innovations in the regulatory pathway.
  5. List limitations to the currently available technology that require research or device modification.
Deliverable

The workgroup will generate two parallel white papers that will outline the current requirements for IDE studies and marketing applications for central venous catheters for hemodialysis and hemodiafiltration systems, and identify issues that should be considered in assessing the benefit and risk for these devices.

Timeframe for Completion

Fall 2016.

Workgroup:
Co-chairs:

Stephen R. Ash, MD, FACP
Stephen R. Ash MD, FACP is an interventional nephrologist and entrepreneur, representing American Society of Diagnostic and Interventional Nephrology (ASDIN). Dr. Ash is a Nephrologist and Clinical Associate Professor, Indiana University Health Arnett Chairman, and Director of R&D, HemoCleanse, Inc. and Ash Access Technology, Inc., Lafayette, Indiana.

Douglas M. Silverstein, MD
Douglas M. Silverstein, MD is a pediatric nephrologist and a Medical Officer in the Renal Devices Branch (RNDB) of the Center for Devices and Radiological Health (CDRH) at the FDA.

Central Venous Catheters Subgroup:

Timothy Clark, MD
Penn Presbyterian Medical Center

Jeffery Cooper, DVM
Center for Devices and Radiological Health (CDRH), FDA

Amy Dwyer
University of Louisville

Marius Florescu, MD
University of Nebraska Medical Center

Garth James, PhD
Montana State University

Frank Hurst, MD
Center for Devices and Radiological Health (CDRH), FDA

Wing Ng
Medtronic, Inc.

Roman Shingarev, MD
University of Alabama at Birmingham

Scott Trerotola, MD
University of Pennsylvania

Bridget Wildt, PhD
Center for Devices and Radiological Health (CDRH), FDA


Hemodiafiltration Subgroup:

Benard Canaud, MD
Fresenius Medical Care - Germany

Greg Collins, PhD
Nephros, Inc.

William Fissell, MD
Vanderbilt University

Gema Gonzalez, PhD
Center for Devices and Radiological Health (CDRH), FDA

Shani Haugen, PhD
Center for Drug Evaluation and Research (CDER), FDA

Robert Kossmann, MD, FACP, FASN
Fresenius Medical Care - North America

Todd Snell
NxStage Medical, Inc.

Jim Summerton
Nephros, Inc.

Jorg Vienken, PhD
Nephro-Solutions AG - Germany

Shen Xiao, MD
Center for Devices and Radiological Health (CDRH), FDA


KHI Board of Directors Liaison

Carolyn Y. Neuland, PhD
Dr. Neuland is the Chief of the Renal Devices Branch (RNDB) of the Center for Devices and Radiological Health (CDRH) at the FDA.

Conflict of Interest

To view KHI's Conflict of Interest and Disclosure Policy please click here.

To view the Workgroup Disclosures please click here.