FDA calls for premarket approval applications for denture cushions/pads, repair kit.
This article was originally published in The Tan Sheet
Executive Summary
OTC DENTURE CUSHION/PAD, REPAIR KIT MARKETING APPLICATIONS should include prospective, randomized, controlled clinical trials that evaluate the risk of bone loss and the long-term effects of the devices on oral tissue, FDA said in a proposed call for premarket approval applications (PMAs) for such products. The proposal, published in the July 12 Federal Register, identifies several questions that could be addressed in clinical studies to support PMA applications.