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FDA Draft Enforcement Policy for Certain IVDs: Specific Aspects
The new article highlights certain specific aspects pertaining to the regulatory framework, emphasizing the key points to be taken into consideration.
The new article highlights certain specific aspects pertaining to the regulatory framework, emphasizing the key points to be taken into consideration.
The article highlights the key points related to the regulatory framework for remanufacturing medical devices, outlining the main considerations and critical aspects.
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.