FDA
The new article provides additional details regarding specific aspects associated with remote regulatory assessments.
FDA
The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.
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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