A traditional 510(k) can be filed under any circumstance. There is no Premarket Notification 510(k) form to complete, but a 510(k) is a document containing information required under 21 CFR 807 Subpart E and is based on the concept of substantial equivalence to a legally marketed 'predicate' device, providing a comparison between the device to be marketed and the predicate device or devices.
Traditional 510(k)s usually follow a standard '20 chapter' format, in accordance with guidance provided by FDA. From January 2013, paper submissions must also be accompanied by an 'eCopy' that meets FDA requirements. An initial screening by FDA will take place once the eCopy has been accepted, and the submission will not be subjected to substantive review until this 'Refuse to Accept' (RTA) screening has been successfully completed.
GEAMR can help you to identify any device specific guidance documents from the FDA and FDA-recognised consensus standards, as well as general guidance, for instance for any necessary biocompatibility testing or software validation. In addition, we can help you to identify the relevant design control requirements of the Quality System regulation, as much of the information and data developed to meet design controls will be required in the 510(k) submission.