128. Significant Risk or Non-Significant Risk Device Determination

Investigators planning to request Abbreviated IDE are encouraged to review the documentation that came with the device. Generally, the device sponsor (or manufacturer) will make the initial determination of whether a device presents a significant risk (SR) or NSR. As noted previously, all SR device research requires an IDE.

Significant Risk Device Studies

  • Briefly, SR devices present a potential for serious risk to the health, safety, or welfare of a subject (see definitions for details).
  • SR device studies require the sponsor to submit an IDE application to the FDA.
  • Investigators must provide evidence of IDE to the IRB.
  • SR device studies are reviewed at convened IRB meetings.

If information about device risk is not provided, investigators are encouraged to communicate with the device sponsor or manufacturer, and the FDA to verify the status of the device as non-significant risk and to obtain the necessary information for IRB assessment of device risk.

Non-Significant Risk Device Studies

For a list of NSR devices, see http://www.fda.gov/oc/ohrt/irbs/devices.html#risk)

  • A NSR device is one that does not meet the definition of a SR device.
  • NSR device studies do not require submission to the FDA but must comply with abbreviated requirements at §812.2(b) (see above).
  • NSR device studies are not necessarily minimal risk studies.
  • NSR studies generally require review at a convened IRB meeting but may be reviewed via expedited procedures if the criteria for expedited review are met.
  • NSR studies must receive IRB approval prior to commencing.

Although the sponsor or manufacturer may assess a device as NSR, the Biomedical IRB will make the final determination. The IRB considers the following in assessing a NSR device study:

  1. information in the protocol application or device instruction manual or brochure including

a.    descriptions of the device and its proposed use and

b.    the nature and seriousness of the harm that may result from the use of the device or from procedures required for use of the device (e.g., surgical implants);

2.    reports of prior investigations conducted with the device;

3.    the proposed investigational plan; and

4.    descriptions of subject selection criteria and safety monitoring procedures.

The investigator must provide the following additional materials for IRB consideration of NSR devices:

•     sponsor's risk assessment and rationale for its determination as NSR and

•     FDA's assessment of the device's risk if such an assessment has been made.

If the IRB disagrees with the sponsor determination of NSR device and designates the device as SR, the following occurs:

  1. The investigator will be informed of the IRB's determination in writing and the investigator must notify the sponsor.
  2. The IRB will require that the sponsor submit to the FDA for an IDE.
  3. The IRB will not approve the study until the IDE is obtained or until official communication is provided indicating FDA determination of NSR.

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