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1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
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18. Ancillary Committees
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20. Policies Specific to Certain Types of Research
21. Informed Consent
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23. Vulnerable Populations
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Basic Folder Information

20.5 Investigational Devices


Text Block

Review Responsibility:

IRB Policy and Procedure Committee

  Current Approval Date:

April 15, 2013


20.5 Investigational Devices

Clinical investigations of devices are subject to the Investigational Device Exemptions (IDE) regulations, 21 CFR 812.

An approved IDE permits a device that is not approved (via premarket authorization, PMA) or cleared for marketing (via 510(k)) by the FDA to be shipped to conduct clinical investigations of that device. Significant risk investigational devices must have an IDE issued by FDA before they can be shipped. If an investigational device does not have an Investigational Device Exemption (IDE) number, the IRB must categorize the device as either “significant risk” or “non-significant risk.”

Under 21 CFR 812.3(m), a significant risk device means an investigational device that:

  1. Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
  2. Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
  3. 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
  4. Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

A non-significant risk device is one that does not meet the definition for a significant risk device. A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of studies involving non-significant risk devices are not required to submit an IDE application to FDA for approval. Submissions for nonsignificant device investigations are made directly to the IRB of each participating institution. Sponsors should present an explanation to the IRB where the study will occur of why the device does not pose a significant risk. If the IRB disagrees and determines that the device poses a significant risk, the sponsor must report this finding to FDA within five working days [§812.150(b)(9)]. FDA considers an investigation of a nonsignificant risk device to have an approved IDE when IRB concurs with the nonsignificant risk determination and approves the study.

When research is conducted to determine the safety or effectiveness of a non-significant risk device, the institution confirms that the device fulfills the requirements for an abbreviated IDE (21 CFR 812.2(b)91):

  • The device is not a banned device;
  • The sponsor labels the device in accordance with 21 CFR 812.5
  • 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;
  • The sponsor ensures 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;
  • The sponsor complies with the requirements of 21 CFR 812.46 with respect to monitoring investigations;
  • The sponsor maintains the records required under 21 CFR 812.140(b)(4) and (5) and makes the reports required under 21 CFR 812.150(b)(1) through (3) and (5) through (10);
  • The sponsor ensures that participating investigators maintain the records required by 21 CFR 812.140(a)(3)(i) and make the reports required under 21 CFR 812.150(a)(1), (2), (5) and (7); and
  • The sponsor complies with the prohibitions in 21 CFR 812.7 against promotion and other practices.

The risk determination should be based on the proposed use of a device in an investigation, and not on the device alone. For a device study to be eligible for expedited review, it must involve a non-significant risk device and the research must present no greater than minimal risk to the subject (21 CFR 56.110). If the IRB makes an initial determination that a device under study is non-significant risk and that the study is “minimal risk,” the convened IRB may vote to expedite the study at the time of continuing review assuming no change in risk level in the interim.

If the IRB decides the device is of “significant risk,” the investigator must be notified of the decision, the investigator must notify the sponsor to obtain an IDE number, or, if there is no sponsor, the investigator must contact the FDA to obtain an IDE number or a letter from the FDA stating that an IDE for that device is not required. Clinical investigations that are exempt from IDE regulations still require IRB review and approval. An investigation of a medical device in human subjects research that is exempt from the IDE regulations must fall into one of the following categories (criteria in 21 CFR 812.2(c)):

  • A device legally marketed in the US that is used or investigated in accordance with the indications in the FDA-approved labeling.
  • A diagnostic device (that is, an in vitro diagnostic device) 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 in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.
  • 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.

In vitro diagnostic (IVD) device investigations may be exempt from the IDE requirements of 21 CFR 812 if the devices are properly labeled and meet the criteria set forth in 21 CFR 812.2(c)(3). However, such studies are still subject to the FDA regulations and IRB review requirements if the research is to support an application for research or marketing of the device (see 21 CFR 50.1). This is true regardless of whether the samples to be used are individually identifiable or not. The FDA regulations define a subject to include a human on whose specimens an investigational device is used (21 CFR 812.3(p)). Thus, an IVD study to support a premarket submission to the FDA is considered a human subject investigation and is subject to IRB review under 21 CFR 50 and 56. IVD research may be eligible for expedited review and without informed consent if the study involves leftover human specimens and as long as subject privacy is protected by using only specimens that are not individually identifiable, when appropriate.

In addition to the above, FDA Guidance on informed consent for in Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable makes clear that IRB review is one of several criteria for IVD studies using leftover specimens that are not individually identifiable.

On September 8, 1995, FDA entered into an agreement with the administrator of the Medicare program, the Health Care Finance Administration (HCFA), to provide information about devices under an IDE to aid in its reimbursement decisions. [Please note that HCFA is now known as the Centers for Medicare & Medicaid Services (CMS).] Under this agreement certain devices could be viewed as “reasonable and necessary” by Medicare and treatments could be covered if all other applicable Medicare coverage requirements are met. Specifically, FDA will place all IDEs it approves in one of two categories:

Category A - Experimental

The IDE involves innovative devices in which “absolute risk” has not been established (i.e., initial questions of safety and effectiveness have not been resolved and thus FDA is unsure whether the device type can be safe and effective)

Category B - Investigational; Non-experimental

The clinical investigation involves device types believed to be in classes I or II or device types believed to be in class III where the incremental risk is the primary risk in question.

Class I medical devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls which cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labeling, notification of the FDA before marketing the device, and general reporting procedures. Devices in this category include tongue depressors, bedpans and other similar types of common equipment.

Class II medical devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls. Special controls may include special labeling requirements, mandatory performance standards, and post market surveillance. Class II medical devices are held to a higher level of assurance than Class I medical devices in that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material.

Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Therefore, these devices require a premarket approval (PMA) application under section 515 of the FD&C Act in order to obtain marketing clearance.

The IRB will include the following statement in the informed consent document for applicable IDE Category B device studies as indicated in written communication from the FDA documenting the IDE number and the category B device designation:

“You or your insurance company will be billed only what the University will pay to obtain the device from the manufacturer.”

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