The New and Improved 510(k) RTA: Permitting FDA Discretion

By Allyson B. Mullen –

In August, CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance). This change was done with so little fanfare that many did not even notice – we did not even blog on it. We recently realized, however, that the new RTA policy warranted discussion, and FDA should be commended for the changes it instituted.

You may recall that we previously blogged on some of the foolish RTA comments we saw in CDRH’s first year of implementing the 510(k) RTA policy.  The changes made to the 510(k) RTA policy appear to try to curb some of these mindless RTA comments by giving “FDA staff . . . discretion to determine whether missing checklist items are needed to ensure that the submission is administratively complete to allow the submission to be accepted.” New RTA Guidance at 7. Reviewers are also now permitted to “request missing checklist items interactively from submitters during the RTA review.” Id. We read this as allowing reviewers to request outstanding items from submitters without formally refusing the submission. While we have yet to see such interactive review employed by reviewers, permitting such flexibility is positive compared to rigid application of a checklist.

CDRH also implemented several changes to the checklists to address this new discretionary, “common sense” approach. Some of these examples are seen in the Traditional 510(k) RTA Checklist and include:

• The requirement for drawings, schematics, etc. now states “submission includes a statement that engineering drawings, schematics, etc. are not applicable to the device (e.g., device is a reagent and figures are not pertinent to describe the device).” Although companies are still required to state that this item is not required, it appears CDRH is trying not to be inflexible with its requirements.
• The introductory questions in the Sterilization and Biocompatibility sections, now asks if this information is not provided because it is “not needed for [the] device (e.g., software-only device).”
• The introductory questions in the Software and EMC and Electrical Safety sections now asks if this information was not addressed because it is “not needed for this device (e.g., surgical suture, condom).” We hope this new question will prevent future requests for software information for vinyl gloves as we discussed in our previous RTA blog post.

Reviewer discretion is not always a good thing, however. We recently heard about FDA refusing a 510(k) during the RTA review because a company did not provide a copy of its sterilization protocol and report. While this request may not seem unreasonable, the RTA expressly says, “the sterilization validation report is not required.” Traditional RTA Checklist at 13 & Abbreviated RTA Checklist at 15. Thus, while we commend FDA for attempting to make the RTA process more reasonable by allowing discretion, this discretion should not be used to permit reviewers to unilaterally expand the checklist requirements by asking for items the checklist expressly indicates are not required.

A few other changes of note in the Traditional 510(k) Checklist include:

• The Traditional 510(k) RTA checklist no longer requires companies to include copies of the Standards Data Report Form (FDA Form 3654) for all national or international standards referenced in the submission. We expect, however, that during the 510(k) review, reviewers will still ask for copies of the Standards Data Report Form.
• If the subject device is intended to be marketed with multiple components, accessories, and/or as part of a system, the 510(k) must now not only indicate the 510(k) numbers for the associated components, accessories, and system parts, but it must also expressly specify which components, accessories, and system parts are not cleared.
• The checklist now recommends a tabular format for performing the predicate device comparison. We hope this recommendation does not restrict submitters from using whatever format it thinks is best to compare the proposed and predicate devices.
• The checklist now indicates that any differences in indication for use, intended use or technological characteristics between the proposed and predicate devices must be expressly stated. This requirement appears to be more substantive than administrative because in order to determine if any differences have been expressly stated, the reviewer performing the RTA would need to substantively assess the predicate device comparison.
• For products labeled “non-pyrogenic,” the submission must include a description of the methods used to assess pyrogenicity.

It is too soon to tell if these changes and FDA’s attempt at increased reviewer discretion will translate into more reasonable RTA reviews. It does, however, show how even seemingly low-key, unpublicized changes to checklists can affect the processing of 510(k)s.