FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
EU
The article provides an overview of the approach to be applied when calculating regulatory fees associated with registration and authorization for medicines intended to be marketed and used in Ireland.
FDA
The article provides a general overview of the existing regulatory framework associated with adverse events.
FDA
The article provides an overview of the new regulation and highlights the key points associated thereto.
CDRH
This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...
