In a recent announcement, the Food and Drug Administration (FDA) has unveiled the availability of its innovative eSTAR tool for select voluntary Premarket Approval (PMA) submissions related to medical devices. Earlier in October, the FDA had mandated the use of eSTAR for 510(k) medical device submissions, accompanied by the release of a comprehensive Guidance Document. […]
FDA Introduces eSTAR Tool for Voluntary Premarket Approval Submissions in the Medical Device Industry

