Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?
Health Law Advisor
SEPTEMBER 5, 2023
Frankly, FDA’s regulation is general and does not specifically require any particular performance metrics be stated. 1] As a result, while all five metrics are different, they all are probative of the general concept of accuracy and so I grouped them together for purposes of this study.
Let's personalize your content