Unless exempt by the IDE regulations, all medical devices utilized in human research activities must be classified as a Significant Risk (SR) or a Non-Significant Risk (NSR).
Significant Risk (SR) Device: A device that presents potential for serious risk to the health, safety, or welfare of a participant and is intended as
1) an implant; or
2) is used in supporting or sustaining human life; or
3) is of substantial importance in diagnosing, curing, mitigating or treating disease, otherwise prevents impairment of human health; or
4) otherwise presents a potential for serious risk to the health, safety, or welfare of participants.
Determining Non--Significant Risk and Significant Risk
The sponsor or manufacturer of the medical device initially makes a determination that the device will be categorized as a Non-Significant Risk (NSR) or a Significant Risk Device (SR). If it is determined that it is a SR device, the sponsor or manufacturer must submit a request for an IDE from the FDA. Research involving the use of a SR device must be conducted in accordance with the full requirements of the FDA and must have an IDE.
When the sponsor or manufacturer determines that the device is a NSR device, an IDE is not required and research must be conducted in accordance with the “abbreviated” requirements of the FDA as described in Federal regulations 21 CFR 812.2(b) and CPHS approval of a study as a NSR can be sought, thus expediting the process. If CPHS agrees that the study is NSR, then submission to or review by FDA is not necessary before starting studies in humans. However, if CPHS considers the study to be SR, the sponsor must obtain an IDE from FDA.
Once received, CPHS will determine if it is in agreement with the determination of NSR status by the sponsor and proceed with its reveiw. If CPHS disagrees with the sponsor’s NSR ruling, the investigator must report the CPHS determination to the sponsor. The sponsor will then decide if they wish to pursue approval through the FDA and obtain an IDE or cease attempts at seeking CPHS approval at this institution.
CPHS has the authority to disapprove research activities even when the FDA has granted approval of the device.
Depending on which category the device falls under, the Investigator must do the following in their CPHS protocol:
Significant Risk Devices |
Investigator must obtain the IDE number |
Non-Significant Risk |
Investigator must provide supporting documentation of this determination from the sponsor |
Devices granted an exemption (see below) |
Investigator must provide supporting documentation from the sponsor of the specific category of exemption under FDA regulations |
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