FDA
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
United States
The article provides a brief overview of the existing legal framework associated with the third-party review.
FDA
The new article covers some specific aspects associated with the evidential expectations for implantable devices, such as human factors, clinical performance testing, and labeling.
FDA
The article outlines the general considerations for evidentiary expectations and describes in detail the authority’s non-clinical recommendations.
FDA
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
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