Regulation of Medical Devices

Regulation of Medical Devices

1. A non-significant risk (NSR) device study is one that does not meet the definition of a significant risk (SR) device study. Thus, a NSR study is not for a device that:

i. Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;

ii. 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;

iii. 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; or

iv. Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

Investigators are responsible for determining the initial device risk and presenting it to the institutional review board (IRB). The IRB is then responsible for reviewing the risk determination and modifying it if the board disagrees. If the FDA has already made the risk determination for the study, that determination is final. The FDA is also available to help the sponsor, clinical investigator, and IRB in making the risk determination. FDA regulations 21 CFR 812.2 also states that for studies involving use of an investigational device, the investigator must obtain either a "significant risk" Investigational Device Exemption (IDE) from the FDA, or a determination of "non-significant risk" from the institutional review board (IRB). The FDA’s “Guidance for Institutional Review Boards and Clinical Investigators” provides such criteria for the investigator and IRB to use in making these decisions.

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... pumped out by the ventricle per heartbeat) also experience higher rates of fracture, further supporting the claim that the Sprint Fidelis leads were vulnerable to normal physiological stresses. Data released on the Sprint Fidelis electrodes suggest survival probability following 8 years to be as low as 58%, compared to similar leads with a 91% chance of survival. Medtronic should perform more diligent mechanical testing to mimic the increased activity of younger patients who need an ICD. There is a fine balance between strength and stiffness, as the lead must be able to conform to various shapes to facilitate implantation and accommodate for patient movement while still able to handle cyclical stresses over a number of years. Medtronic could instead pick a new material with similar conductance yet a more suitable Young’s Modulus for future generations of ICD leads.