It is the policy of UTHSC-H that when research is conducted to determine the safety or effectiveness of a device, the device must have an Investigational Device Exemption (IDE) issued by the FDA, unless the device meets the requirements for an abbreviated IDE (21 CFR 812.2(b)(1)) or the protocol meets one of the five exemptions from requirement for IDE (21 CFR 812.2(c))
Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the Public Health Service Act.
Investigation means a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device.
Investigational device means a device, including a transitional device that is the object of an investigation.
Significant risk device means an investigational device that:
§ Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
§ Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
§ Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
§ Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Sponsor-investigator means an individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. The term does not include any person other than an individual. The obligations of a sponsor-investigator include those of an investigator and those of a sponsor.
Unanticipated adverse device effect means any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
The Principal Investigator submits information on the device with the initial application form via iRIS. The Principal Investigator includes information on the device including FDA issuance letter, IDE number and plan for storage and dispensing.
If the Principal Investigator has provided an IDE number, ORSC Staff will confirm that the device has an IDE and that the IDE number is valid by matching the IDE number with the sponsor protocol, communication from the sponsor or communication from FDA. In case the IDE is held by the investigator, ORSC Staff will match the number with communication from FDA.
If the device does not have an IDE, ORSC Staff determines if the research meets FDA exemptions from requirement to have an IDE. If the research meets an exemption criteria, ORSC Staff will document it and bring it to the attention of the Reviewer.
as listed below:
a. 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.
b. 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 equivalence.
c. A diagnostic device, if the sponsor complies with applicable requirements in 809.10(c) and if the testing:
i. Is noninvasive,
ii. Does not require an invasive sampling procedure that presents significant risk,
iii. Does not by design or intention introduce energy into a subject, and
iv. Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
d. 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.
e. A custom device as defined below, unless the device is being used to determine safety or effectiveness for commercial distribution. A custom device is one that:
i. Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
ii. Is not generally available to, or generally used by, other physicians or dentists;
iii. Is not generally available in finished form for purchase or for dispensing upon prescription;
iv. Is not offered for commercial distribution through labeling or advertising; and
v. Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
Research proposals involving a device that is exempt from IDE requirements may qualify for expedited review. If the device does not have an IDE and the protocol does not meet the exemptions, ORSC Staff will assign the proposal for review at a full board meeting. CPHS shall review the Sponsor’s determination of significant risk device or a non-significant risk device to determine if an IDE is required.
Significant risk (SR) or non significant risk (NSR) device determination - The assessment of whether or not a device study presents a SR or NSR is initially made by the sponsor. If the sponsor considers that a study is NSR, the sponsor provides an explanation of its determination and any other information that may assist CPHS in evaluating the risk of the study. The sponsor should provide a description of the device, reports of prior investigations with the device, the proposed investigational plan, a description of patient selection criteria and monitoring procedures, as well as any other information that CPHS deems necessary to make its decision. The sponsor should provide information regarding whether other IRBs have reviewed the proposed study and what determination was made. The sponsor should provide FDA’s assessment of the device's risk if such an assessment has been made. CPHS may also consult with FDA for its opinion.
CPHS shall make the SR or NSR determination about a study by reviewing relevant information at a full board meeting. This information includes the description of the device, reports of prior investigations conducted with the device, the proposed investigational plan, subject selection criteria, and sponsor’s rationale used in making its SR or NSR determination
CPHS may agree or disagree with the sponsor’s initial NSR assessment. If CPHS determines the study is NSR, CPHS may approve the study as per policy and procedure Initial Review and the study may begin without submission of an IDE application to FDA.
If CPHS disagrees with the sponsor’s NSR assessment and decides the study is SR, CPHS will inform the Principal Investigator, and where appropriate, the sponsor. CPHS will review the study as per policy and procedure Initial Review. CPHS may defer or approve the study pending, but ORSC will not issue an approval letter until the Principal Investigator has provided a copy of FDA’s approval or conditional approval letter or written communication from FDA that states that the device is NSR.
ORSC Staff will document the SR or NSR determination in the meeting minutes. The minutes shall describe CPHS reason for its SR or NSR determination and may also include the documentation used to establish the IDE status for the study. For an SR determination, such documentation may include, for example, a copy of the IDE approval or conditional approval letter from FDA. For an NSR determination, the documentation may include FDA's NSR determination.
In the event the FDA determines that an investigational device is SR after the sponsor and CPHS have determined the device to be NSR, CPHS will follow guidance from FDA on whether to continue or suspend the study.
CPHS shall ensure that the Principal Investigators plan for control of investigational device is appropriate. In general, pharmacy service should be used for storage and dispensing of the investigational device. CPHS may approve of a plan to store and dispense investigational device by an experienced Investigator or Study Coordinator in certain situations such as industry sponsored research with a plan for monitoring.
1. 21 CFR 812 Subpart D – IRB Review and Approval
2. 21 CFR 812.43(c)
3. 21 CFR 812.100
4. 21 CFR 812.140
REFERENCES TO OTHER SOP
1. Initial Review.
1. Medical Device Panel on CPHS Application Form.
If you find errors in this document, contact firstname.lastname@example.org
1 Aug 2008
1 Jan 2009
1 Aug 2011
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iRIS HELPLINE 713-500-7960
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