FDA
The new article highlights the questions related to the impact of the actions committed by the applicant on the FDA review clock. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has...
FDA
The new article highlights the aspects related to the initial review of submissions, including the stages of the review process. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulatory agency in the sphere of healthcare products, has...
FDA
The new article highlights the aspects related to certain specific cases when the review clock will stop due to the decisions taken by the authority. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The article provides an overview of the regulatory requirements related to the actions to be taken by the authority and/or applicant in the context of premarket notification, and the effect such actions will have on the review timelines. Table Of Contents: The Food...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a final guidance document dedicated to the submission of 510(k) notifications for changes to medical devices that have already been...
