The regulator issued guidance to go over the necessary elements and contents of a complete 510(k) submission in a bid to enhance the consistency of acceptance decisions.
The guidance document, Refuse to Accept Policy for 510(k)s, describes the procedures and criteria the FDA will use to evaluate whether a 510(k) submission should be accepted for substantive review. It’s meant to provide FDA staff with a “clear, consistent approach for acceptance review for traditional, special and abbreviated 510(k) notifications.”
The guidance document covers pre-submission interaction, policies and procedures, and principles, and includes checklists and tables.
The 510(k) acceptance review is aimed at evaluating whether a submission is “administratively complete,” meaning it contains all the information required for the FDA to review and determine substantial equivalence. In order for a device to be substantially equivalent, the regulator must determine it has the same intended use as the predicate device, and either has the same technological characteristics or has different technical characteristics, but the submission includes information showing the device as being as safe and effective as the predicate. The device can’t raise different safety and effectiveness questions.
According to the guidance, the FDA will base its acceptance review of all traditional, special or abbreviated 510(k)s on objective criteria using the applicable Acceptance Checklist included in the document. The submission can only be accepted if all the administrative elements identified as RTA items are included — or the submitter has provided an explanation for elements that were omitted. The FDA has, however, the discretion to decide whether a missing checklist element is required in order for the submission to be complete and accepted, and can request a missing item interactively during the review. If a submission isn’t accepted, the submitter can respond to the RTA notification by providing the omitted information.
The FDA also goes over the basic principles of its review policies and procedures, stating that acceptance will be based on whether submissions contain all the necessary elements to start a substantive review. The information’s adequacy to support a finding won’t be considered — this is only considered during the substantive review. The FDA also says it must determine whether a justification was provided for any alternative approaches or element omissions, and if so, must determine its adequacy. The agency will also consider any device-specific and cross-cutting guidances, as well as applicable recognized standards and regulations when making RTA determinations.
The document contains a preliminary questions checklist, going over questions that should be answered by reviewers as an initial screening of the submission. The FDA lists six preliminary questions, including whether the submission is with the appropriate center, whether the device type is eligible for a 510(k) submission and whether there is a pending PMA for the same device with the same indication for use, among others.
A checklist of eight items covers acceptance review. The FDA goes over organizational elements and elements of a complete submission, which are explicitly necessary to a substantive submission review and substantial equivalence determination. The document also explains how to apply the checklist, and how to deal with elements marked “not applicable” and “no.” The list also covers conversions of special 510(k)s to traditional ones, with the FDA noting it developed separate checklists to address the nuances in content for special and traditional 510(k) submissions.
The guidance ends with three tables — “Acceptance Checklist for Traditional 510(k)s,” “Acceptance Checklist for Abbreviated 510(k)s” and “Acceptance Checklist for Special 510(k)s” — which should be completed and included as part of submissions.