FDA
The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.
FDA
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
FDA
The article outlines the scope of information to be included in premarket submissions depending on the sterilization methods used.
FDA
The new article addresses the matters related to the information to be included in notifications the parties responsible for medical devices should submit.
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
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