Clinical evaluation of medical devices - download pdf or read online

By Karen M. Becker, John J. Whyte

The unique variation of this article, medical assessment of scientific units: ideas and Case experiences, supplied the 1st assessment of key pr- ciples and methods to clinical machine medical trials, illustrated with a chain of special, real-world case stories. The publication is designed as a source for medical pros and regulatory experts operating within the box of latest scientific gadget improvement and advertising. because the first version of this article was once released in 1997, the fast velocity of inno- tion in health and wellbeing care applied sciences maintains to yield interesting and significant new items. The regulatory panorama has additionally developed, reflecting a few of the alterations and wishes in the clinical equipment undefined. the aim of scientific overview of clinical units: ideas and Case reports, moment version is to supply an up-to-date and accelerated presentation of the clinical tools and regulatory specifications utilized to the learn of latest major chance scientific units. The textual content now comprises (1) new info at the requisites and strategy for gaining repayment of latest items from Medicare and personal insurers, with case stories of study in particular designed for this p- pose in addition to future health care know-how overview equipment; (2) infor- tion on new statistical methodologies utilized to scientific equipment trials; and (3) all new case reports, together with examples of mix pr- ucts, three-phase improvement types (i. e. , feasibility, FDA approval, Medicare reimbursement), and novel learn designs.

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Example text

There has been a failure to comply with any applicable legal requirement. 10. The application contains an untrue statement of material fact or omits material information required by the FDA’s regulations. 11. The sponsor has not responded to a request for additional information. 12. There is reason to believe that the risks associated with the device’s benefits do not outweigh its risks or that the device is ineffective. 13. 4. 160 Periods when a subject might use the device beyond the investigation include extended investigations, while the sponsor is preparing the marketing application, and while FDA is reviewing the application.

Regulatory Requirements for Clinical Studies 35 2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent. 3. Any additional costs to the subject that may result from participation in the research. 4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject. 5. A statement that significant new findings developed during the course of the research that may be related to the subject’s willingness to continue participation will be provided to the subject.

6. The sponsor of the clinical trial has not pursuing marketing approval or clearance with due diligence. 7. Approval of the IDE for the controlled clinical trial has been withdrawn. 8. The clinical investigators named in the treatment IDE are not qualified based on their scientific training and/or experience. 46 Kracov and Dwyer 9. There has been a failure to comply with any applicable legal requirement. 10. The application contains an untrue statement of material fact or omits material information required by the FDA’s regulations.

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