FDA
The new article refers to additional resources to be taken into consideration by the parties involved in operations with laboratory-developed tests.
EU
The new article describes in detail the approach to be applied when it comes to the re-assessment of designation under the new regulatory framework.
EU
The new article highlights certain specific aspects associated with designation, such as notification procedure or changes to the scope of designation.
EU
The new article clarifies the aspects associated with the designation decision to be taken with respect to the applicant entity in the context of the CAB/NB designation process.
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
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