The new article provides additional details regarding specific aspects associated with remote regulatory assessments.
RegDesk Regulatory Roundup
The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.
The new article covers some specific aspects associated with the evidential expectations for implantable devices, such as human factors, clinical performance testing, and labeling.
The article outlines the general considerations for evidentiary expectations and describes in detail the authority’s non-clinical recommendations.
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
The article outlines the scope of information to be included in premarket submissions depending on the sterilization methods used.