FDA
The article describes the approach to be followed when submitting information related to sterilizing medical devices intended to be marketed and used in the US.
FDA
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
FDA
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
FDA
The new article highlights the aspects related to the review process itself.
FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
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