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.
RegDesk Regulatory Roundup
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.
The new article highlights the aspects of the documentation the authority expects to be submitted for review.
The article provides a brief overview of the existing legal framework associated with the third-party review.
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.
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.