"Conducting Clinical Trials A-Z"

Special Consideration for Device Studies

(FDA Approval, Medicare reimbursement issues & UK Technology Assessment Committee Review)

FDA Center for Devices and Radiological Health
Device Advice is CDRH's self-service site for medical device and radiation emitting product information. Device Advice is an interactive system obtaining information concerning medical devices.

To begin the FDA approval process for a medical device, the sponsor must verify the device classification in order to determine the necessary approval route.

Class I – minimal risk device that is exempt from FDA approval process.

Class II – devices with some risk and more regulatory oversight, some exempt and others nonexempt from approval.

Class III – devices intended for life support, are implantable or otherwise high risk.

Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database can be found at: http://www.fda.gov/cdrh/devadvice/313.html 

When a sponsor believes that the device is essentially equivalent to a legally marketed device, they submit the data to FDA on a Premarket Notification 510(k).  FDA will make a determination of equivalency to allow marketing or will require a Premarket Approval (PMA).  The PMA application is used for high-risk devices and requires clinical trials to support claims for the device.

Clinical trials using unapproved medical devices on human subjects are performed under an Investigational Device Exemption (IDE). Clinical studies with devices of significant risk must be approved by FDA and by an Institutional Review Board (IRB) before the study can begin. Studies with devices of non-significant risk must be approved by the IRB only before the study can begin.  The IRB may however determine that the device should be considered significant-risk necessitating FDA approval.

A description of the IDE process and information on FDA requirements for conducting a clinical study of an unapproved medical device can be found at:
http://www.fda.gov/cdrh/devadvice/ide/index.shtml

In addition to the IDE, the FDA requires precautionary labeling the device as investigational.  Labeling guidelines may be found at: http://www.fda.gov/cdrh/devadvice/33.html

During the clinical trials, the device should be evaluated for safety with attention to adverse events, malfunctions, and user mistakes.

Upon receipt of the PMA, the sponsor may market the device.   Once marketed the FDA uses Postmarket Surveillance and Medical Device Reporting to monitor possible problems or adverse effects of the device.  A sponsor must maintain device tracking for implanted devices for more than a year in the event of a recall.

 The FDA permits a sponsor to charge an investigator or study subject for an investigational device.  The charge is limited to the cost of manufacturing, research, development, and handling and the subject must be told of the charge in the informed consent.   Medicare classifies these devices to assist in determining payment coverage during the clinical trial period.

Medicare Reimbursements - Devices

Category B devices, as well as the hospital and physician services surrounding these devices, may be reimbursed by Medicare for Medicare patients.  In addition, routine cost associated with Category A devices that are used to treat an immediate, life-threatening condition, (defined as a stage of disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment), may also qualify, but the device will remain non-covered.  To receive this reimbursement, the Hospital must gain approval from the Medicare Medical Director.  This process is coordinated through the Managed Care Finance department of the Hospital and the required information must be submitted to Medicare at the inception of the Study.  The Medicare approval process ranges from four to six weeks in duration. Contact Elaine Younce for more information on devices at 859 257-9521.

UK Technology Assessment Committee
All investigational and non-investigational devices must be submitted for review and approval of the Technology Assessment Committee.  Complete the request form and submit with protocol and other supporting documents.  If you have questions regarding your submission, contact Lorra Miracle, RN, Value Analysis/PI Facilitator/UHC Liaison at 323-4745 or pager 2706.