FDA Draft Guidance on Animal Studies for Dental Bone Grafting Material Devices: Data Collection
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
The new article provides additional recommendations to be taken into consideration when preparing the submission, in particular with respect to study design and execution.
The article provides an overview of the existing legal framework and also describes the key concepts related to the matter.
The new article describes in detail the approach to be followed when evaluating medical devices impacting, intentionally or unintentionally, the temperature of human tissues.
The article provides a general overview of the existing legal framework, highlighting the key points to be considered by the parties interested in placing their products on the US market.
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report