Abstract
Development engineers must document conformance of medical products to requirements, and be able to show that the established specifications result in a product that meets user needs. By following the basic steps for Design Control and Review, biomaterials which serve as device components can be demonstrated safe and effective for sale in the global medical device market. Medical device regulations and best practices for evaluating biomaterials in new medical products change faster than book chapters can be updated. This chapter has a broad outline of the regulatory structures. Assessment of the safety and effectiveness of new (and the ongoing evaluation of approved) medical devices is challenging. The Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, X-ray systems, ultrasound equipment, microwave ovens, and color televisions. Thus, CDRH plays an essential role in promoting and protecting the public health by ensuring that medical devices marketed in the United States provide a reasonable assurance of safety and effectiveness and confer a favorable risk–benefit profile for their intended use population.
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