New Medical Device Approval
No medical device ( supplies, accessories, or equipment), whether purchased, contracted, donated, loaned or for trial, may be used in the Medical Center for inpatient or outpatient care purposes without first being evaluated by Clinical Engineering. The Food and Drug Administration (FDA) defines a medical device as any instrument, apparatus, or other article that is used to prevent, diagnose, mitigate, or treat a disease or to affect the structure or function of the body, with the exception of drugs. This means that the FDA classifies common hospital products such as catheters, thermometers, patient restraints and syringes as medical devices. In order to obtain approval, submit the New Medical Device Request From online using the "Visit Website" link to the right. Research teams using a new medical device in their clinical research must complete and submit the New Medical Device form for to the Clinical Engineering for review prior to the study being submitted for HSR-IRB approval. This approval is prompted in CRConnect when applicable and managed by Clinical Engineering.