Zdrowie i gospodarka · 27/09/2018

FDA Reclassifies Single-Use Female Condom to Single-Use Internal Condom, Reducing Regulatory Burden

The US Food and Drug Administration (FDA) is reclassifying the single-use female condom to a class II device, subject to premarket notification (510(k)), and renaming it to single-use internal condom, reducing the need for a premarket approval application (PMA) and associated regulatory burden.