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1. What is a medical device?
The FDA regulations define items that are considered medical devices. A medical device is defined, in part, as any health care product that does not achieve its primary intended purposes by chemical action or by being metabolized. Medical devices include, among other things, surgical laser, wheelchairs, sutures, pacemakers, vascular grafts, intraocular lenses, and orthopedic pins. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis (IVD) of disease and other medical conditions such as pregnancy. Clinical investigations of medical devices must comply with FDA informed consent and IRB regulations. Please note: The FDA regulations apply to ALL medical device studies, whether the device is marketed or not.
There are two possible classifications for investigational medical devices:
Please see the FDA Information Sheets for examples of SR and NSR devices.
The distinctions between the two device risk categories are:
a) A SR device poses a “potential for serious risk to the health, safety, or welfare of a subject.” Such devices may only be studied under an Investigational Device Exemption (IDE) granted by the FDA. A device is SR (and requires an IDE) if it:
b) Non-significant risk devices do not meet the above definition. The assessment of whether or not a device study represents a NSR is initially made by the sponsor/investigator. The IRB will then determine if the NSR designation is appropriate. If the IRB disagrees with the NSR claim, it will require the sponsor/investigator to submit an IDE application to the FDA.
The FDA has the ultimate authority to determine if a device study presents a “significant risk” or “nonsignificant risk.” If the FDA disagrees with the IRB’s decision that a device study presents a “nonsignificant risk”, an Investigational Device Exemption (IDE) application must be submitted to the FDA before the device is used in a clinical study. Additionally, if a sponsor/investigator presumes a device to be SR and submits an (IDE) to the FDA , the FDA may disagree and classify that study as “nonsignificant risk.” In this case, the FDA will return the IDE application with the recommendation that it should be presented to the IRB as a “nonsignificant risk” study.
An IDE is issued by the FDA to allow the use investigational devices in human subjects. The IDE permits use of the device in a clinical investigation to evaluate the safety and/or efficacy of the investigational medical device. An IDE may be held either by a commercial sponsor or by a physician-investigator. Clinical studies of SR investigational devices must comply with FDA’s investigational device exemption (IDE) regulations and be conducted only with IRB approval. More information is available at this site: http://www.fda.gov/. If an investigational device is a “non-significant risk device”, an investigator does not need to submit an IDE; the IDE will be “considered approved” under FDA regulations. Such devices do not have to comply with FDA premarket approval and performance standards prior to use in research studies. Such studies of devices “considered approved” by the FDA must still be submitted to the IRB for approval prior to use in human subject research.
The FDA provides procedures for the use of an investigational device outside the parameters of an approved protocol. In the case of a serious disease, a device may be made available after the completion of all the clinical trials. If an “immediately life-threatening disease” presents, an investigational device may be made available for treatment use prior to the completion of the research.
Investigators must contact the FDA to discuss “compassionate treatment” using an investigational device outside of an IRB approved protocol and must obtain IRB approval for this use. The FDA will consider the use of an investigational device under a treatment IDE if:
a) the device is intended to treat or diagnose a serious or immediately life-threatening disease or condition;
b) there is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of the disease or condition;
c) the device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed;
d) the sponsor of the investigation is actively pursuing marketing approval/clearance of the investigational device with due diligence.
FDA approval of compassionate use of an investigational device must precede use of that device.
There are five possible device studies that are exempt from the FDA regulations on IDEs. These exemptions apply only so long as the investigator remains qualified to conduct the research (see FDA regulations, 21 CFR 812.119 for Disqualification).
i. Devices, other than transitional devices, in commercial distribution prior to May 28, 1976, when used or investigated in accordance with labeling in effect at that time;
ii. Devices, other than transitional devices, introduced into commercial distribution on or after May 28, 1976, that the FDA determines to be substantially equivalent to a device in commercial distribution prior to May 28, 1976, and which is used or investigated in accordance with approved labeling;
iii. A diagnostic device (including in vitro diagnostic products in compliance with 21 CFR 809.10(c)if the testing:
a. Is non-invasive
b. Does not require an invasive sampling procedure that presents significant risk
c. Does not by design or intention introduce energy into a subject, and
d. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
iv. Devices undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution , if the testing is not for the purpose of determining safety or effectiveness and does not put the subject at risk.
v. Custom devices, as defined by FDA in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.
A sponsor/investigator, must submit an application to the FDA for approval of an IDE if:
A sponsor/investigator may not begin a study for which FDA approval of an IDE application is required until the FDA has issued its approval and the IRB has approved the study.
A device with an FDA 510(k) Designation.
FDA regulations allow a manufacturer/sponsor to claim that a new device is substantially equivalent to models that the FDA has already approved for marketing. Such devices are granted a 510(k) designation. The manufacturer/sponsor must apply to the FDA for this designation, and the FDA will provide a letter in response indicating whether or not it is granted. IRB approval is still required before an investigator may conduct research using a device with a 510(k) designation.
Yes, the clinical study of a new indication for an already marketed device falls under the IDE regulation. The JHM IRB must review the device for its new investigational application. If there are questions, the investigator and/or the IRB may contact the FDA IDE Staff at :
9200 Corporate Blvd.
Rockville, MD 20850
12. IRB review of device studies:
Both SR and NSR device studies must be reviewed by a JHM IRB. In the case of an NSR claim, the initial assessment of whether or not the device study is NSR is made by the sponsor/investigator. The IRB then determines whether that assessment is appropriate. If an NSR study qualifies as “minimal risk” under Federal regulations; then the IRB may choose to use an expedited review procedure. The risk determination made by the IRB will be based upon both the nature of the device AND the proposed use of the device in the study.
If a device does not meet the criteria for an expedited review procedure, the study must be reviewed at a convened IRB meeting, regardless of whether the device is SR or NSR. All IRB requirements for human subject research apply to any medical device research study conducted at Hopkins regardless of whether investigators seek exemption from IDE requirements.
In 1995, the FDA and the Health Care Financing Agency (HCFA), now the Centers for Medicare & Medicaid Services (CMS), entered into an interagency agreement to categorize devices in clinical trials for purposes of eligibility for coverage by Medicare. There are two categories of devices: Category A (experimental/investigational devices for which there is no Medicare coverage); and Category B (non-experimental investigational devices). FDA will notify the sponsor (whether a commercial sponsor or a physician-investigator) of an investigational device clinical trial (i.e., a device with an IDE) of its decision regarding the category assigned to a device.
Category B devices will b eeligible for Medicare coverage. The rule states that: "Payment for covered devices and related services will be based on, and may not exceed, the amount that would have been paid for a currently used FDA-approved device and related services serving the same medical purpose." NSR device investigations for which the FDA does not require submission of an IDE are deemed to be in Category B. You are reminded, however, that JHM IRB must make the decision as to whether a device is SR or NSR.
Medicare will not provide payment for Category A devices, and will not pay for "services related to a non-covered device." Investigators who wish to conduct clinical trials of devices that are determined to be Category A devices must address cost issues with the sponsor to assure that Medicare patients are not adversely affected by the decision to participate.