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.
EU
The article highlights the aspects related to studies involving combination products, the ones not initially intended to assess the safety and performance of a medical device, and other specific cases.
United States
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
ACTD
The article provides a brief overview of the approach to be applied concerning the classification of medical devices. It highlights the key points to be taken into consideration in this respect.
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.
