Download Clinical Evaluation of Medical Devices: Principles and Case by Karen M. Becker PhD (auth.), Karen M. Becker PhD, John J. PDF

By Karen M. Becker PhD (auth.), Karen M. Becker PhD, John J. Whyte MD, MPH (eds.)

Highly praised in its first version, scientific assessment of scientific units: ideas and Case stories, moment version has been increased and up to date to incorporate the various concepts and medical learn tools that experience constructed because the first version, in addition to present details at the regulatory, criminal, and repayment atmosphere for scientific units. The book's deeply skilled authors summarize the foremost ideas and techniques hired in clinical machine medical trials and illustrate their makes use of in a revealing sequence of specified, real-world case reviews. Highlights contain new info at the specifications and technique for gaining repayment from Medicare and personal insurers on new products-including case reviews of analysis in particular designed for this purpose-and new statistical equipment utilized to clinical machine trials. extra case stories supply examples of mixture items, three-phase improvement types (i.e., feasibility, FDA approval, and Medicare reimbursement), and novel learn designs. The instances reveal quite a lot of designs which were effectively utilized to many alternative examine difficulties, in addition to to a number of healing or diagnostic products.
Authoritative and hugely sensible, scientific overview of clinical units: ideas and Case stories, moment variation, presents a gold-standard source for medical execs and regulatory experts operating on the leading edge of recent therapeutics, diagnostics, and scientific equipment improvement and advertising today.

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Extra info for Clinical Evaluation of Medical Devices: Principles and Case Studies

Sample text

The person who directly oversees the administration of a device to a Regulatory Requirements for Clinical Studies 25 test subject). 26 The FDA does not hesitate to issue warning letters to investigators who fail to comply with these general responsibilities. 1. Financial Disclosure Requirements When reviewing studies included in marketing applications, the FDA may consider clinical studies inadequate if it determines that the studies are biased. 2. 35 Once the FDA has received such information, the Center for Devices and Radiological Health (CDRH) will give the investigator written notice of the matter and offer the investigator an opportunity to explain it in an informal conference.

7. The name and address of any institution where part of the investigation may occur that has not yet been identified. 8. If the device will be sold, the price of the device and an explanation of why the sale does not qualify as commercialization. 9. An environmental assessment or a claim for categorical exemption from the requirement. 10. Copies of all labeling for the device. 11. Copies of all informed consent forms and informational materials that will be given to study subjects. 12. 79 Notably, the FDA provides an administrative checklist that sponsors can use to ensure that their applications are complete.

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 approximate number of subjects involved in the study. As part of the IDE process, the FDA must review and approve sample informed consent documents to ensure that they contain the necessary information.

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