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Ulations 21 CFR part 812 describe two types of device studies; "significant risk" (SR) and "nonsignificant risk" (NSR). Significant risk device 21 CFR 812.3(m) means an investigational device that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject; (.
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Gui01007 FAQ
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As discussed, FDA is the final arbiter in deciding whether a device study poses a significant or nonsignificant risk. It should be noted, however, that FDA generally only sees those studies that sponsors submit to the agency or those studies for which an IRB or clinical investigator asks for FDA's opinion.
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Examples of SR devices include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants. Conversely, non-significant risk (NSR) device studies do not pose a significant risk to patients. Non-significant risk should not be confused with “minimal risk,” a term used by the FDA to classify studies.
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Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and Foley catheters. A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study.
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Nonsignificant risk devices are devices that do not pose a significant risk to the human subjects. Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and Foley catheters. A nonsignificant risk device study requires only IRB approval prior to initiation of a clinical study.
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Final answer: A non-significant risk trial, as determined by an IRB, is best characterized by requiring less paperwork. These trials are still subject to ethical review, and their status does not impact the likelihood of adverse effects or volunteers' health status involved.
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Examples of SR devices include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants. Conversely, non-significant risk (NSR) device studies do not pose a significant risk to patients. Non-significant risk should not be confused with “minimal risk,” a term used by the FDA to classify studies.
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Non-significant risk (NSR) device A NSR device is one that does not meet the definition of a SR device. Examples: Low-power lasers for treatment of pain and daily-wear contact lenses. See the FDA info sheet for more examples.
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Under 21 CFR 812.3(m), an SR device means an investigational device that: • 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.
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