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PubMed

Regulatory strategies for early device development and approval.

PMID: 35485732 ·

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RevistaCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
Ano
PMID35485732

Resumo

The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies suc

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