significant risk device

significant risk device

An FDA term of art for 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 for use in supporting or sustaining human life, and represents a potential for serious risk to the health, safety or welfare of a subject;
(3) 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
(4) Otherwise presents a potential for serious risk to a subject.
 
FDA-approval is required for investigation of significant risk devices, which include artificial skin, catheters, extended-wear contact lenses, prosthetic heart valves, and ventilators.
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References in periodicals archive ?
Yearly updates are recommended for a significant risk device that's not well understood.
If the study involves a significant risk device, the IDE must also be approved by the FDA.
A study involving a significant risk device is always a significant risk study, but a study involving only non-significant risk devices can also be a significant risk study,(19) depending on how the devices are used.
The rigor and expense of the clinical trials process varies depending upon whether the device is determined to be a "significant risk device" or "nonsignificant risk device." Otolaryngologists should be aware that such regulations exist and may influence greatly the viability of creative new device concepts (including surgical instruments and, particularly, implants) because the costs associated with federal approval can be prohibitive.
The new edition has been updated to reflect technological and regulatory change and includes chapters on regulatory requirements for clinical studies of medical devices and diagnostics, requirements for Medicare coverage and reimbursement for medical devices, post-market requirements for significant risk devices, intellectual property protection for medical devices, compliance with the Health Insurance Portability and Accountability Act of 1996 in clinical research, developing drug- device combination products with unapproved component's, and Wall Street's perspective on medical device evaluation.

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