FDA
The article provides a general overview of the existing legal framework, paying attention to the most important regulatory matters.
FDA
The new article describes in detail certain specific aspects pertaining to the regulatory requirements dental composite resin devices should comply with in order to be allowed for marketing and use in the US.
Australia
The article outlines the key requirements in the context of exporting certain medical devices from Australia.
FDA
The new article provides further clarification on the regulatory policy, emphasizing the key aspects to be considered in order to ensure compliance with the relevant regulatory requirements.
FDA
The new article refers to additional resources to be taken into consideration by the parties involved in operations with laboratory-developed tests.
BfArM
The article outlines the key points related to reporting serious adverse events in the context of clinical trials.
