By Karen M. Becker, John J. Whyte
The unique version of this article, medical review of scientific units: rules and Case reviews, supplied the 1st assessment of key pr- ciples and ways to clinical machine scientific trials, illustrated with a chain of specified, real-world case stories. The publication is designed as a source for medical execs and regulatory experts operating within the box of latest clinical equipment improvement and advertising and marketing. because the first version of this article was once released in 1997, the quick speed of inno- tion in health and wellbeing care applied sciences maintains to yield intriguing and critical new items. The regulatory panorama has additionally developed, reflecting a few of the adjustments and desires in the scientific machine undefined. the aim of medical evaluate of clinical units: ideas and Case experiences, moment variation is to supply an up to date and multiplied presentation of the medical tools and regulatory necessities utilized to the examine of latest major threat clinical units. The textual content now contains (1) new info at the standards and method for gaining repayment of recent items from Medicare and personal insurers, with case reviews of study particularly designed for this p- pose in addition to future health care know-how evaluate tools; (2) infor- tion on new statistical methodologies utilized to scientific equipment trials; and (3) all new case experiences, together with examples of mixture pr- ucts, three-phase improvement versions (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel research designs.
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Additional info for Clinical evaluation of medical devices
167 Typically, if IVDs are truly exempt from the IDE requirements and comply with the labeling requirement, the FDA’s Division of Bioresearch Monitoring will refrain from issuing warning letters for IDE requirement violations, except in unusual circumstances. Even in unusual circumstances, it would not issue a warning letter without first consulting the Office of Chief Counsel, the OC, and the ODE management. If the IVD testing fails to meet the criteria for exemption from IDE requirements, the IDE, IRB, and informed consent requirements apply.
123 Notably, the FDA’s published guidelines on acceptable monitoring approaches124 require that sponsors provide written monitoring procedures for all studies involving more than one investigator. Sponsors are also responsible for securing compliance with the signed agreement, the investigational plan, the IDE regulations, and other conditions imposed by the FDA or an IRB. Sponsors who discover that an investigator is not complying must discontinue shipments of the device to the investigator promptly and terminate the investigator’s participation in the study.
Additionally, during the clinical studies, certain behavior, such as promotion or commercialization of the investigational device, is prohibited. 1. 108 Because the FDA established the informed consent regulations in part to protect patients, the regulations require informed consents to contain adequate information in understandable language to allow patients to determine whether to participate in the study. They also require that the patients have adequate time to consider participation in the study, to minimize the possibility of coercion or undue influence.