SGS Recommends Changes to Test Plan for FDA 510(k) Premarket Submissions for Medical Face Masks
The U.S. Food and Drug Administration (FDA) has clarified the requirements for 510(k), a premarket submission that demonstrates a medical device is safe and effective before it is marketed. The clarification has increased the sample size requirements for medical face masks. To market Class I, II, or III medical devices for human use in the […]
