Aurora IRB#: / Protocol title:
Primary Reviewer: / Research Compliance Analyst:
Reviewer Checklist for Devices
q YES / q NO / Does this protocol evaluate the safety or effectiveness of a device in research subjects, a control group, or their biological specimens?q YES / q NO / Does this submission involve a Humanitarian Use Device (“HUD”)?
Is either answer is “YES”, complete the appropriate sections of checklist.
If the answer is “NO”, FDA device regulations (21CFR812) do not apply. This checklist is complete and may be signed and filed. Give consideration to whether protocol is FDA-regulated, that is, whether data may be submitted to FDA for marketing or labeling.
IDE/HDE Requirements (One must be “YES”. If all are “NO”, consult with RSPP Manager, as FDA may need to be contacted)
q YES / q NO / The protocol has an IDE or HDE (If “YES”, complete IDE/HDE Validation section below)q YES / q NO / The submission indicates the device qualifies for an abbreviated IDE (“NSR”) (If “YES”, complete Abbreviated IDE section below)
q YES / q NO / The submission indicates ALL devices qualify as exempt from IDE requirements (If “YES”, complete IDE Exemptions section below)
IDE/HDE Validation (At least one must be checked, and if not, the IDE/HDE cannot be validated – consult with RSPP Manager)
q Sponsor protocol imprinted with the IDE number.
q Written communication from the sponsor documenting the IDE/HDE number.
q Written communication from the FDA documenting the IDE/HDE number.
Abbreviated IDE (Non-Significant Risk device “NSR”) determination (All must be checked)
q The device is not banned.
q The device is not a significant risk device (all of the following must be true):
· The device is not intended as an implant and does not present a potential for serious risk to the health, safety, or welfare of a subject;
· The device is not purported or represented to be for use supporting or sustaining human life and does not present a potential for serious risk to the health, safety, or welfare of a subject;
· The device is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and does not present a potential for serious risk to the health, safety, or welfare of a subject; or
· The device does not otherwise present a potential for serious risk to the health, safety, or welfare of a subject.
q The investigator/sponsor will label the device in accordance with FDA regulations (21 CFR 812.5).
q The IRB will review the research and confirm that the device is a non-significant risk device and that consent will be obtained and documented in accordance with FDA regulations.
q The investigator/sponsor will comply with FDA requirements for monitoring investigations (21 CFR 812.46).
q The investigator/sponsor will comply with requirements for records and reports (21 CFR 812.140, 21 CFR 812.150).
q The investigator/sponsor will not market or promote the device (21 CFR 812.7).
IDE Exemptions: ALL devices falls into one of the categories of exemption from Part 812 (and does not require IDE):
q Exemption [812.2(c)(1) or 812.2(c)(2)] [ALL of the following must be true]
· The device was not regulated as a drug before enactment of the Medical Device Amendments (Transitional Device).
· The device is FDA-approved/cleared1.
· The device is being used or investigated in accordance with the indications in the FDA-approved/cleared labeling.
q Exemption [812.2(c)(3)] [ALL of the following must be true]
· The device is a diagnostic device.
· The sponsor will comply with applicable requirements in 21 CFR 809.10(c).
· The testing is noninvasive.
· The testing does not require an invasive sampling procedure that presents significant risk.
· The testing does not by design or intention introduce energy into a subject.
· The testing is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure.
q Exemption [812.2(c)(4)]
· The device is undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, and the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.
q Exemption [812.2(c)(7)]
· The device is 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.
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RCA/Primary Reviewer Date
1 In commercial distribution immediately before May 28, 1976, or 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.
SC 504-B 2/21/11