FDA Amends Regulations for Gold-Based and Precious Metal Alloys, Exempts from Premarket Notification Requirements

Summary

The FDA is designating special controls for gold-based and precious metal alloys used in dental devices, and exempting them from premarket notification requirements, as part of its efforts to modernize the regulation of these devices under the Federal Food, Drug, and Cosmetic Act and the Safe Medical Devices Act of 1990.