When research is conducted to determine the safety and/or effectiveness of a medical device, the device must have an Investigational Device Exemption (IDE) issued by the FDA (21 CFR 812.2(a)), unless the device as used in the study meets the requirements for an abbreviated IDE (21 CFR 812.2(b)(1)) or meets the criteria for IDE exemption (21 CFR 812.2(c)).
Medical Device means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
Investigation means a clinical investigation or research involving one or more subjects to determine the safety and/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 means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.
Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.
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.
When the research assesses the safety and/or effectiveness of a medical device, the Principal Investigator (PI) will submit device information with the initial application via iRIS, including but not limited to:
- FDA determination status/issuance letter
- IDE Number
- Rationale for IDE exemption, or rationale for Nonsignificant Risk (NSR) determination, as applicable
- Product information document that lists device indications for use (i.e., “instructions for use,” “user manual,” “operating manual,” etc.).
- Plan for storage and dispensing of investigational device
IRB staff will confirm that these items have been added to iRIS.
Confirmation of IDE Number:
If the PI has provided an IDE number, then the regulatory reviewer will confirm that the IDE number is valid by any of the following methods:
- For studies in which the UTHealth PI is not the sponsor-investigator (that is, there is an industry sponsor that holds the IDE, or the study is multi-site and an institution other than UTHealth is the lead site that initiated the study and holds the IDE), at least one of the following must be submitted to the IRB:
- Sponsor protocol documenting the IDE number.
- Written communication from the sponsor documenting the IDE number.
- Written communication from the FDA documenting the IDE number.
- For studies in which the UTHealth PI is the sponsor-investigator (that is, the UTHealth PI holds the IDE), one of the following must be submitted to the IRB:
- If the protocol is submitted with an initial IDE application, written communication from the FDA documenting the IDE number.
- If the protocol is submitted to an existing IDE, written communication from the FDA documenting that FDA has approved the supplement submitted to the existing IDE to add the new protocol.
Review for IDE Exemption:
If a study that assesses the safety and/or effectiveness of a medical device does not have an IDE, then the regulatory reviewer will evaluate whether the device as used in the study meets FDA IDE exemption criteria and will document the findings in iRIS under Reviewer Checklist and Comments. The regulatory reviewer may call on the expertise of IRB members for assistance in determining IDE exemption, for instance, in determining whether or not a device is used in accordance with the FDA approved indications. Additionally, CPHS may ask that the UTHealth PI request an IDE exemption determination from FDA.
The Study is IDE exempt if one of the below categories applies:
- The device is FDA-approved via PMA or FDA cleared via 510(k), and is being used or investigated in accordance with the indications in the FDA approved/cleared labeling
- A diagnostic device, if the sponsor complies with applicable requirements in 809.10(c) and if
- the testing is noninvasive;
- Does not require an invasive sampling procedure that presents significant risk;
- Does not by design or intention introduce energy into a subject; and
- Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
- 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.
- 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:
- 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;
- Is not generally available to, or generally used by, other physicians or dentists;
- Is not generally available in finished form for purchase or for dispensing upon prescription;
- Is not offered for commercial distribution through labeling or advertising; and
- 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.
- 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.
- 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.
For studies that are exempt from the IDE regulations, the IRB does not need to decide whether the study poses a significant risk or nonsignificant risk. However, the IRB must still review the study in accordance with the IRB regulations before the investigation may begin. Research proposals involving a device that is exempt from IDE requirements may qualify for expedited review.
Significant Risk (SR) or Nonsignificant Risk (NSR) Device Determination:
FDA considers the significant risk (SR)/nonsignificant risk (NSR) determination to be part of the IRB’s responsibilities for conducting its initial review of a study, and unless FDA has already made a risk determination for the study, the IRB needs to make an SR/NSR determination. Sponsors or sponsor-investigators are responsible for making the initial SR/NSR determination and presenting it to the IRB. IRBs or sponsors may request a risk determination from FDA, and FDA will be the final arbiter.
If the UTHealth PI has initiated the study and there is no industry sponsor or other lead site, the regulatory reviewer will prompt the IRB to make an SR/NSR determination via comments in iRIS under Review Checklist and Comments. The IRB shall determine whether the device as used in the study is SR or NSR 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 the PI’s rationale for an SR or NSR determination. IRB reviewers should consider the potential for serious risk to the health, safety, or welfare of a subject and base the risk determination on the proposed use of a device in an investigation, and not on the device alone. The IRB may also ask that the UTHealth PI request an SR/NSR determination from FDA.
When the IRB determines that a study is SR, the IRB will require that the PI submit an IDE application to FDA. The IRB may defer or approve the study pending, but IRB staff will not issue an approval letter until the PI has provided a copy of FDA’s approval or conditional approval letter or written communication from FDA that states that the device is NSR. SR device studies must follow all of the IDE regulations at 21 CFR 812 and must have an IDE application approved by FDA before they may proceed. NSR device studies must follow the abbreviated requirements at 21 CFR 812.2(b), including requirements for device labeling, IRB approval, informed consent, monitoring, records, reports, and prohibition against promotion; however, IDE applications do not have to be submitted to FDA for NSR device studies.
IRB staff will document the SR or NSR determination in the meeting minutes. The minutes shall describe the IRB’s reason for the 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.
SR/NSR Determination When the UTHealth PI is Not the Sponsor-Investigator: If the UTHealth PI is not the sponsor-investigator [that is, there is an industry sponsor that serves as the IDE sponsor, or the study is multi-site and an institution other than UTHealth is the lead site that serves as the IDE sponsor], then the lead IRB overseeing the IDE sponsor will make an SR/NSR determination for the study as a whole; however, UTHealth CPHS shall review the SR/NSR determination made by the lead IRB and must agree with the determination before approving the study locally at UTHealth. If FDA has determined SR or NSR, then FDA is the final arbiter, and CPHS will move forward with FDA’s determination.
FDA Determination of SR After IRB Determination of NSR: In the event the FDA determines that an investigational device is SR after the sponsor and responsible IRB have determined the device to be NSR, CPHS will follow guidance from FDA on whether to continue or suspend the study.
Review of Plan for Storage and Dispensing of Investigational Device:
CPHS shall ensure that the PI’s plan for control of the investigational device is appropriate. In general, the pharmacy service should be used for storage and dispensing of the investigational device. CPHS may approve of a plan to store and dispense the investigational device by an experienced Investigator or Study Coordinator in certain situations, such as industry-sponsored research with a plan for monitoring.
APPLICBLE REGULATIONS AND GUIDANCE
- Investigational Device Exemptions
- FDA IDE Guidance - Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors – Significant Risk and Nonsignificant Risk Medical Device Studies
- FDA IDE Guidance - Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors – Frequently Asked Questions About Medical Devices
REFERENCES TO OTHER SOP
- Initial Review
- Regulatory Review
- Medical Device Panel - CPHS Application Form
If you find errors in this document, contact email@example.com
Executive Director, Research Compliance
1 Aug 2008
1 Jan 2009, 1 Aug 2011, 1 Jun 2016, 19 Jan 2018, 1 Jun 2021
CPHS HELPLINE 713-500-7943
iRIS HELPLINE 713-500-7960
UTHealth’s Compliance Hotline (1-888-472-9868)
IRB OFFICE HOURS Thursdays from 1 to 4pm, via the Teams Room at this link
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