Global Regulatory Pulse

Update on FDA’s Clinical Trials Program for Medical Devices

In Clinical, FDA, Regulatory by Kristy Katzenmeyer-Pleuss

On July 14, 2016, FDA hosted a webinar to provide an update on two topics related to medical device clinical trials: Early Feasibility Studies (EFS) and publication of the draft guidance “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicaid Services (CMS) with Coverage Decisions”. Archives of the webinar, presentation slides, and transcript can be found on FDA’s website. Here, we highlight some of the key items discussed in FDA’s webinar for these two topics. NAMSA has also previously provided a general background on EFS and FDA’s EFS program.

EFS

In their webinar, FDA highlighted that EFS conducted in the US may help streamline the device commercialization process since it may be easier to leverage data from the intended patient population (i.e., the US population) for subsequent clinical studies. Key elements of the EFS IDE guidance published in October 2013 were also highlighted, including informed consent recommendations, additional patient monitoring, and more frequent reporting to FDA for EFS compared to traditional clinical studies. Importantly, contingent approval for EFS may be possible for anticipated device changes or future completion of specific long-term studies in some cases if there is prior agreement between FDA and the sponsor on the test plan, including test protocols, methods, and acceptance criteria that will be used. FDA also stated that they recognize that for EFS, which are conducted with a small number of patients, alternatives to nonclinical testing methods or leveraging of data may be necessary. For example, ability to use single lot sterilization validation and leveraging biocompatibility data from certain studies.

Finally, FDA recommended that sponsors contact their division EFS representatives to discuss submission strategy to help guide successful EFS IDE submissions. Below is the contact information for the various EFS division representatives in the Center for Devices and Radiological Health (CDRH)’s Office of Device Evaluation (ODE) as well as the Office of Science and Engineering Laboratories (OSEL):

Office/Division Name Email
EFS Program Leader Carla Wiese Carla.Wiese@fda.hhs.gov
EFS Medical Advisor Andrew Farb, M.D. Andrew.Farb@fda.hhs.gov
ODE/DAGRID Joel Anderson, Ph.D. Joel.Anderson@fda.hhs.gov
Joy Samuels-Reid, M.D.
(pediatric specialist)
Joy.Samuels-Reid@fda.hhs.gov
ODE/DCD Hiren Mistry (ICDB, PIDB, VSDB) Hiren.Mistry@fda.hhs.gov
Rob Kazmierski (CDDB, CEDB, IEDB)  Robert.Kazmierski@fda.hhs.gov
 Katie Wallon (CSDB, SHDB)  Katherine.Wallon@fda.hhs.gov
ODE/DNPMD  Erin Keegan  Erin.Keegan@fda.hhs.gov
 Devjani Saha, Ph.D.  Devjani.Saha@fda.hhs.gov
ODE/DOD  Jemin Dedania Jemin.Dedania@fda.hhs.gov
 Charles Warner  Charles.Warner@fda.hhs.gov
 Krutanjali Shah  Krutanjali.Shah@fda.hhs.gov
ODE/DOED  Tieuvi Nguyen, Ph.D.  Tieuvi.Nguyen@fda.hhs.gov
 Angelo Green, Ph.D., DABT  Angelo.Green@fda.hhs.gov
ODE/DRGUD  Andrew Fu, Ph.D.  Andrew.Fu@fda.hhs.gov
 David Birsen  David.Birsen@fda.hhs.gov
ODE/DSD  Thomas (Ted) Claiborne, Ph.D.  Thomas.Claiborne@fda.hhs.gov
OSEL  Maureen Dreher, Ph.D.  Maureen.Dreher@fda.hhs.gov
 Christopher Scully, Ph.D. Christopher.Scully@fda.hhs.gov

DAGRID: Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
DCD: Division of Cardiovascular Devices
DNPMD: Division of Neurological and Physical Medicine Devices
DOD: Division of Orthopedic Devices
DOED: Division of Ophthalmic and Ear, Nose and Throat Devices
DRGUD: Division of Reproductive, Gastro-Renal, and Urological Devices
DSD: Division of Surgical Devices
ICDB: Interventional Cardiology Devices Branch
PIDB: Peripheral Interventional Devices Branch
VSDB: Vascular Surgery Devices Branch
CDDB: Cardiac Diagnostics Devices Branch
CEDB: Cardiac Electrophysiology Devices Branch
IEDB: Implantable Electrophysiology Devices Branch
CSDB: Circulatory Support Devices Branch
SHDB: Structural Heart Devices Branch

The EFS representatives are planned to be present with the review team in EFS submission meetings to help communicate any issues to the EFS staff, aid in the decision making process, and “ensure that the EFS spirit is taken into consideration”.

Draft Guidance on FDA Categorization of IDE Devices to Assist with CMS Coverage Decisions

When first approving an IDE, FDA will categorize the device into Category A (experimental/investigational) or Category B (non-experimental/investigational), which is included in the approval letter and is used by CMS in its determination for Medicare coverage. Those devices falling under Category A may not be covered by Medicare, but routine care/services may be covered. For Category B devices, the investigational device as well as the routine care/services and related services may be covered. It’s important to note that the device categorization is only one element used by CMS in its determination and there are other factors that may affect coverage, such as whether there has already been a relevant national coverage decision made that may supersede FDA’s category designation or whether other CMS criteria have been met. For non-significant risk studies in which an IDE is not required, no category is assigned by FDA. Therefore, sponsors need to contact a local Medicare contractor to request coverage. CMS typically reviews coverage requests within approximately thirty days and IDE studies that have been approved for CMS coverage are listed on the CMS website every Friday. Once an IDE study is listed on the CMS website, coverage for the study is approved for each study site (i.e., it is not necessary for each study site to submit their own coverage request).

On June 1, 2016, FDA published the draft guidance “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicaid Services (CMS) with Coverage Decisions”. FDA stated that the new guidance was created to better define criteria for studies such as feasibility studies, provide guidance in how changes in category designation from A to B can occur, and include consideration for new regulatory pathways such as de novo submissions. In the webinar, FDA provided several examples of Category A versus Category B devices with the key difference between the categories being whether or not information exists to resolve initial questions of safety and effectiveness. FDA also highlighted that additional data gathered on the device (e.g., nonclinical data, preliminary clinical data, data on devices with similar technology) may support a change in device categorization from Category A to Category B after it was first designated by FDA. For example, an EFS IDE could first be designated Category A, but with additional supporting data, a subsequent traditional clinical study could be designated Category B.

Authors:

Kristy Katzenmeyer-Pleuss, Ph.D, is a former FDA medical device reviewer and currently a Senior Medical Research Manager in the Regulatory Department at NAMSA. She holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison. Her experience includes premarket submissions for a variety of device types, including general surgical, dermatologic, cardiovascular, peripheral venous, oncologic, orthopedic, and aesthetic devices.