Feb 19, 2024
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.
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Feb 19, 2024
FDA
The article outlines the general considerations for evidentiary expectations and describes in detail the authority’s non-clinical recommendations.
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Feb 19, 2024
FDA
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
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Feb 19, 2024
FDA
The new article addresses the matters related to the information to be included in notifications the parties responsible for medical devices should submit.
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Feb 1, 2024
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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