FDA
The article highlights the key points associated with the use-related risk analyses to be conducted with respect to various healthcare products intended to be marketed and used in the US.
FDA
The new article provides additional clarifications with respect to the development of use-related risk analyses.
FDA
The new article elaborates further on the submission of use-related risk analyses, and also provides certain examples intended to demonstrate the way the regulatory approach described in the guidance should be applied.
Australia
The article highlights the key points related to the application of certain essential principles intended to ensure the safety and proper performance of healthcare products allowed to be marketed and used in Australia.
Australia
The new article provides further details regarding the particular approach to be followed in order to achieve and maintain compliance with the relevant regulatory requirements.
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