150 investigational devices ( i7a) - The Christ Hospital

By Gene Davis,2014-06-06 03:38
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150 investigational devices ( i7a) - The Christ Hospitalthe,THE,The


     ( I.7.A)

    15.1 Background

    A medical device is defined, in part, as any health care product that does not achieve its primary intended purpose by chemical action or by being metabolized. Examples of medical devices include, but are not limited to, surgical lasers, wheelchairs, sutures, pacemakers, vascular grafts or stents, intraocular lenses, orthopedic pins, and radiographic imaging equipment. Medical devices also include diagnostic aids such as reagents and test kits for in vitro diagnosis of disease or other medical conditions such as pregnancy.

    Except for certain low risk devices, each manufacturer who wishes to introduce a new medical device to the market must submit a pre-market notification to the Food and Drug Administration (FDA). The FDA reviews these notifications to determine if the new device is "substantially equivalent" to a device that was marketed prior to the passage of the Medical Device Amendments of 1976 (i.e., a "pre-amendments device"). If the new device is deemed to be substantially equivalent to a pre-amendments device, it may be marketed immediately and is regulated in the same regulatory class as the pre-amendments device to which it is equivalent. Devices determined by FDA to be "substantially equivalent" are often referred to as "510k devices" (i.e., the pre-market notification requirement for new devices is set forth in section 510(k) of the Federal Food Drug and Cosmetic Act). If a new device is deemed not to be equivalent to a pre-amendments device, clinical studies of its safety and effectiveness must be performed and FDA approval granted before the device can be marketed.

    When research involves a drug with an IND or device with an IDE, the IRB Chairman or Primary Reviewer confirms that the IND or IDE number is valid. (Validation can occur by confirming the IND or IDE number on the sponsor protocol, communication from the sponsor, or communication from the FDA. In the cases of investigators who hold the IND or IDE, validation can occur by confirming the number on the communication from the FDA. Investigator brochures should not be used as one brochure since it may be used for multiple INDs or IDEs.)

    15.2 Investigational Devices

    An investigational device is a medical device which is the subject of a human research study to evaluate its safety and/or effectiveness. Clinical studies of investigational devices must comply with FDA's investigational device exemption (IDE) regulations.

    SOP/RM 15 Devices Page 1 of 5

    IRB Review : 02/06/07, 06/01/09, 10/15/09, 07/31/12

     When research is conducted to determine the safety or effectiveness of a

     device, the IRB Chairman or Primary Reviewer confirms that:

    ; The device has an IDE issued by the FDA

    ; The device fulfills the requirements for an abbreviated IDE. [Criteria in 21 CFR 812.2(b)(1)]

    o The device is not a banned device

    o The sponsor labels the device in accordance with 21 CFR


    o The sponsor obtains IRB approval of the investigation after

    presenting the reviewing IRB with a brief explanation of

    why the device is not a significant risk device, and

    maintains such approval.

    o The sponsor ensure that each investigator participating in

    an investigation of the device obtains from each subject

    under the investigator’s care, consent under 21 CFR 50 and

    documents it, unless documentation is waived.

    o The sponsor complies with the requirements of 21 CFR

    812.46 with respect to monitoring investigations.

    o The sponsor maintains the records required under 21 CFR

    812.150(b) (4) and (5) and makes the reports required

    under 21 CFR 812.150(b) (1) through (3) and (5) through


    o The sponsor ensures that participating investigators

    maintain the records by 21 CFR 812.140(a)(3)(i) and make

    the reports required under 812.150(a) (1), (2), (5), and (7).

    o The sponsor complies with the prohibitions in 21 CFR

    812.7 against promotion and other practices.

    ; The device fulfills one of the IDE exemption categories: [Criteria in 21 CFR 812.2(c)]

    o A device, other than a transitional device, in commercial

    distribution immediately before May 28, 1976, when used

    or investigated in accordance with the indications in

    labeling in effect at that time.

    o A device, other than a transitional device, introduced into

    commercial distribution on or after May 28, 1976, that

    FDA has determined to be substantially equivalent to a

    device in commercial distribution immediately before May

    28, 1976, and that is used or investigated in accordance

    with the indications in the labeling FDA reviewed under

    subpart E of part 807 in determining substantial


    o A diagnostic device, if the sponsor complies with

    applicable requirements in 21 CFR 809.10(c) and if the


    ; Is noninvasive

    SOP/RM 15 Devices Page 2 of 5

    IRB Review : 02/06/07, 06/01/09, 10/15/09, 07/31/12

    ; Does not require an invasive sampling procedure

    that presents significant risk

    ; Does not by design or intention introduce energy

    into a subject

    ; Is not used as a diagnostic procedure without

    confirmation of the diagnosis by another, medically

    established diagnostic product or procedure.

    o A device 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 subjects at risk.

    o A custom device as defined in 21 CFR 812.3(b), unless the

    device is being used to determine safety or effectiveness for

    commercial distribution

    1) IDE Regulations - Significant Risk and Nonsignificant Risk Medical Device Studies

    The IDE regulations (21 CFR part 812) describe two types of investigational device studies, "significant risk" and “nonsignificant risk." A "significant risk" device study is defined as a study of a device that presents a potential for serious risk to the health, safety, or welfare of a subject and/or (1) is an implant; (2) is used in supporting or sustaining human life; or (3) is of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. A "nonsignificant risk" device study is a study of a device that does not fit the definition of a "significant risk" device study. Note that this risk determination should be based not only on the nature of the device, but also on the proposed use of the device in the research study. Two examples follow:

    The research evaluation of a pacemaker that is a modification of a

    commercially available pacemaker is a "significant risk" device

    study because the use of any pacemaker involves the potential for

    serious harm to involved patients. This is true even though the

    modified pacemaker may pose less risk, or only slightly greater

    risk, in comparison with the commercially available product.

    The research evaluation of contact lens wherein the proposed study

    involves its extended wear constitutes "significant risk." Although

    the contact lens, itself, poses minimal risk, wearing it continuously

    for several days/nights presents a potential for injuries not

    normally seen with limited daily use.

    SOP/RM 15 Devices Page 3 of 5

    IRB Review : 02/06/07, 06/01/09, 10/15/09, 07/31/12

    "Significant risk" device studies must be conducted in accordance with the complete requirements of the IDE regulations and necessitate the prospective approval of an IDE application by the FDA and approval by the IRB. In contrast, "nonsignificant risk" device studies are conducted in accordance with "abbreviated requirements" of the IDE regulations and may be approved by the IRB and commence without the requirement for submission of an IDE application to, or other notification of, the FDA. (I.e., for "nonsignificant risk" device studies, the IRB serves as the FDA's surrogate with respect to study review and approval.) Informed consent must be obtained for either type of study.

    2) IRB and Sponsor/Investigator Responsibilities Re. "Significant Risk" or "Nonsignificant Risk" Device Studies

    The determination that a device study presents a "significant risk" or a "nonsignificant risk" is initially made by the sponsor/investigator. If the sponsor/investigator considers the device study to be of "nonsignificant risk", the sponsor/investigator must provide the IRB with an explanation of this determination and copies of the respective research protocol and informed consent document. The sponsor should inform the IRB of the FDA's assessment of the risk status of the proposed device study, if such an assessment has been made. The IRB may question whether other IRB's have reviewed the proposed device study and what determination they made, or the IRB may consult with the FDA for its opinion.

    The IRB may agree or disagree with the sponsor's/ investigator's initial "nonsignificant risk" assessment.

     If the IRB agrees with the determination that the device study

    presents "nonsignificant risk" and approves the research study and

    informed consent document(s), the study may proceed without

    further notification of the FDA. Under this scenario, the sponsor

    and principal investigator are required to comply with the

    "abbreviated requirements" of the IDE regulations (21 CFR


     If the IRB disagrees with the determination that the device study

    presents "nonsignificant risk", the sponsor must notify the FDA

    that the device study has been determined to be of "significant

    risk" and, if electing to proceed with the study, must submit an

    IDE application. The device study may not commence until the

    FDA approves the IDE and the IRB approves the device study and

    informed consent document(s). Under this scenario, the sponsor

    and principal investigator are required to comply with the complete

    IDE regulations (21 CFR 812).

    SOP/RM 15 Devices Page 4 of 5

    IRB Review : 02/06/07, 06/01/09, 10/15/09, 07/31/12

    The FDA has the ultimate decision in determining if a device study

    presents a "significant risk" or "nonsignificant risk." If the FDA, upon

    review of IRB activities, disagrees with the IRB's decision that a device

    study presents a "nonsignificant risk, an IDE application must be

    submitted to the FDA. On the other hand, if a sponsor/investigator

    submits an IDE to the FDA because it is presumed to be a "significant

    risk" study, but the FDA classifies it as a "nonsignificant risk", the FDA

    will return the IDE application with the recommendation that it be

    presented to the IRB as a "nonsignificant risk" device study.

15.3 Adverse Event Reporting

    Please see Section 8.0 “Reporting Unanticipated Problems Involving

    Risks to Human Subjects/Adverse Events”

    SOP/RM 15 Devices Page 5 of 5

    IRB Review : 02/06/07, 06/01/09, 10/15/09, 07/31/12

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