Zdrowie i gospodarka · 04/05/2018

FDA Reclassifies Sharps Needle Destruction Device to Class II for Safer Use

The US Food and Drug Administration (FDA) has reclassified the sharps needle destruction device from Class III to Class II, allowing manufacturers to submit a less burdensome premarket notification (510(k)) instead of a premarket approval application (PMA) for marketing, in an effort to reduce regulatory burdens and enhance device safety.