FDA
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
FDA
The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party review program under the 510(k) framework.
FDA
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
FDA
The new article highlights the aspects of the documentation the authority expects to be submitted for review.
FDA
The article provides a brief overview of the applicable regulatory requirements related to using real-world data in the context of submissions associated with medical devices intended to be marketed and used in the US.
FDA
The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
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