What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)? Who makes the decision, why do they make the decision and how can it effect a clinical trial? Based on the FDA’s guidance for medical device studies and the Regulations, a SR device:
- Is intended as an implant and presents a potential for serious risk to the health, safety or welfare of a subject
- 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
- 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
- Otherwise presents a potential for serious risk to the health, safety or welfare of a subject
In opposition, a NSR is a study that does not meet the definition of SR. Here are some additional differences:
- Must have an Investigational Device Exemption (IDE) application approved by the FDA before the study can proceed
- Must follow all regulations in 21 CFR 812
- Determination of NSR initially made by the Sponsor and then submitted to their IRB
- If the IRB approves the study as NSR, the IRB will oversee the study
- No IDE application needs to be approved by the FDA; therefore the study can be conducted without the FDA being informed
- Will follow abbreviated requirements of 21 CFR 812.2 (b)
The Sponsor or IRB can ask the FDA for help in making a determination of SR vs. NSR. In this case, the FDA’s determination is final. In addition, the Sponsor and IRB can determine the device is NSR and the FDA can decide after the trial is running that the study is SR.
For more information about determining SR vs. NSR, check out our whitepaper!
Have one of your studies ever been effected by FDA’s determination of SR vs. NSR? Please share your thoughts below.
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