This medico-economic study has leaded to choose preferentially the use of minimally invasive surgery techniques. This study also illustrates the discrepancy between the national health system reimbursement and real hospital charges. The medico-economic is becoming critical in the current context of sustainable health resource allocation.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
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