Zdrowie i gospodarka · 16/04/2021

HHS and FDA Disagree with Prior Determination on Class I Medical Gloves

The US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have issued a notice expressing disagreement with a prior determination that seven types of reserved class I medical gloves do not require premarket notification. The agencies are seeking public comment on their current view that these devices do require premarket notification.