FDA Guidance on General Considerations for Animal Studies: Test System Monitoring
The new article highlights the aspects related to monitoring methods and associated matters.
The new article highlights the aspects related to monitoring methods and associated matters.
The new article provides an overview of the regulatory framework for animal studies involving medical devices.
The new article addresses the matters related to the labelling requirements to be fulfilled when placing clinical electronic thermometers on the market.
The new article describes in detail the enforcement policy introduced by the authority and also highlights the key points to be considered in order to comply with it.
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.