FDA Approval Is Not Mandatory for Medical Devices to Be

question 3

True/False

FDA approval is not mandatory for medical devices to be legally sold in the United States.

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Definitions:

IRR

Internal Rate of Return; a metric used in financial analysis to estimate the profitability of potential investments.

Base-Case

A scenario used as a benchmark in analysis, representing the default or most likely set of assumptions.

Sensitivity Analysis

A technique used to determine how different values of an independent variable will affect a particular dependent variable under a given set of assumptions.

Forecasting Risk

The potential for actual outcomes to differ significantly from predicted outcomes in business or financial forecasting models.