Regulatory bodies like FDA may require preclinical studies to initially assess the potential safety and efficacy of new medical devices. The extensive data obtained from preclinical studies includes scientific and medical observations as well as the assessment of relevant physiologic data. These data may be collected at selected time intervals or continuously to provide added insight, such as trends and time course, to a physiologic response. Data collected from continuous preclinical monitoring tends to be less biased, and offers less methodologic “noise” because often the sensors utilized are implanted and the test subjects have accommodated to their placement.
The safety of medical products should be paramount in any determination of whether a product is to be marketed. FDA is charged with evaluating safety and effectiveness as part of its mission to ensure public health and safety while fostering access to new and innovative therapies. The current FDA climate requires significant data and scientific evidence to support approval for commercialization of new device on the US market.
The enhanced insights that continuous preclinical monitoring offers for evaluating pathophysiologic responses to medical interventions offers the potential to speed medical innovation and provide patients with greatly needed medical innovation.
Preclinical monitoring is important and aids in the safety assessment of medical devices prior to market approval. Technology exists to provide comprehensive preclinical study results allowing researchers and engineers to make informed decisions about the safety and effectiveness of a new device under development.
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