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.
United States
The article provides a brief overview of the existing legal framework associated with the third-party review.
United States
The highlights the aspects to be taken into consideration in order to ensure the real-world data used to support regulatory submissions is relevant and reliable.
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