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 ?
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 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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