United States
The article provides additional recommendations related to the description of devices to be included in premarket submissions to ensure the authority has the comprehensive information it needs to complete the review.
United States
The present article outlines the key points related to the existing legal framework and explains the basics of the approach to be followed.
FDA
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.
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.
FDA
The article provides a brief overview of the approach to be followed for the reports related to studies and reports associated with it.
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