The FDA final guidance, entitled “Refuse to Accept Policy for 510(k)s” outlines the assessment procedures and criteria that FDA intends to use to evaluate 510(K) submissions for administrative acceptance. The guidance contains checklists of the FDA recommended elements of a complete submission and indicates that “FDA will base acceptance on the objective criteria outlined in the associated Acceptance Checklist and not on the quality of the data [evaluated during substantive review]”. The ultimate objective of the guidance is to enhance the overall review time by improving the initial quality of 510(k) submissions for acceptance.
Contact us at contact@pearlpathways.com if you need help with a 510(K) submission or regulatory interpretation of the new draft guidance.