Zdrowie i gospodarka · 20/11/2017

FDA Exempts Over-the-Counter Denture Repair Kits from Premarket Notification Requirements

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for over-the-counter denture repair kits, which are intended to mend cracks or breaks on dentures using a resin monomer system. The FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).