127. FDA Regulations: Abbreviated IDE Requirements for Device Research (§812.2(b))
For clinical investigations to determine safety and effectiveness of devices, two categories are considered to have approved applications for IDE's, unless FDA has notified a sponsor that an application is required. Only one of the two categories for "abbreviated IDE requirements" applies to research conducted by University and affiliate researchers.
NOTE: Abbreviated requirements only apply to non-significant risk (NSR) devices (see below for information about device risk).
Abbreviated IDE Requirements
- The device is not a banned device.
- The package labeling does not represent the device is safe or effective, and contains the following information:
a. name and place of business of the manufacturer, packer, or distributor,
b. quantity of contents,
c. statement "CAUTION-investigational device. limited by Federal (or United States) law to investigational use", and
d. relevant contraindications, hazards, adverse effects, interfering substances or devices, warnings, and precautions.
- The sponsor (or sponsor-investigator) presents the reviewing IRB with a brief explanation of why the device is not a significant risk device, and obtains and maintains IRB approval of the investigation prior to implementation.
- The sponsor ensures that each investigator participating in an investigation of the device obtains and documents informed consent from each subject under the investigator's care, unless the IRB approves a waiver of documentation of consent.
- The sponsor complies with the monitoring requirements for investigator compliance, unanticipated adverse device effects, and study termination and resumption (§812.46).
- For NSR devices, the sponsor maintains and makes available the required
a. records including name and use of the device, explanation of NSR assessment, name and address of investigators and reviewing IRBs, and adverse device effects (§812.140(b)(4) - (5)); and
b. reports including unanticipated adverse device effects, withdrawal of IRB or FDA approval, investigator list, progress and final reports, and device recall and disposition (§812.150(b) (1) - (3) and (5) - (10).
- The sponsor ensures that participating investigators maintain and submit the required
a. records documenting informed consent and any uses of the device without informed consent, (§812.140(a)(3)(i)); and
b. reports including unanticipated adverse device effects, withdrawal of IRB approval, and progress and final reports, failure to obtain informed consent (§812.150(a)(1) - (2), (5), and (7)).
- The sponsor complies with the prohibitions against promotion of an investigational device, charging more than the recovery costs for a device, unduly prolonging an investigation, or representing the device as safe or effective (§812.7).
NOTE: The IRB may require documentation from the investigator or FDA to confirm that all the abbreviated requirements have been satisfied.