Zdrowie i gospodarka · 04/12/2017

FDA Proposes to Reclassify Single-Use Female Condom as Class II Device, Reducing Regulatory Burden

The Food and Drug Administration (FDA) is proposing to reclassify the single-use female condom, renaming it the 'single-use internal condom,' from a Class III device to a Class II device, subject to premarket notification (510(k)). This reclassification aims to reduce regulatory burdens on the industry, as devices classified as Class II will no longer require a premarket approval application (PMA) but can submit a less burdensome 510(k) before marketing.