FDA has updated the explanation of how the Agency will process the review of a 510(k).

The most important improvement on the webpage is a color coded chart which provides a time line for each major phase of review.  New in 2013, FDA added the “pre-review” step known as “Refuse to Accept” (RTA).  This first review follows a very detailed checklist based upon the type of submission.  The trip wire in this new review process is the way FDA reviews submissions against any guidance documents and refuses to accept any submission that fails to address ANY item in the guidance document.  The guidance documents often are DRAFT and use terms such as “recommend”, but the RTA review process requires EACH AND EVERY ITEM to be addressed, and an explanation for why it is not, if you are brave enough to think the “guidance” is only a guidance.

Getting through RTA now means the “real review”, known as Substantive Review, has less to review, so the Reviewers are now hard-pressed to find any deficiencies.  We now see increased scrutiny of minor differences between the candidate device and predicates.  Even when the guidance document has not raised a particular performance question, reviewers now find it is necessary to consider that even cosmetic differences are substantial enough to question.

When we prepare your submission now, you will find that we do our best to immolate the type of reviews that FDA is now instituting so that your submission is less likely to encounter FDA deficiencies for petty differences.  We will be increasing our written “arguments” in the submission for substantial equivalence and alerting you when you have introduced a potential issue for FDA finding.  FDA has tightened up on labeling requirements, discussion of animal study protocols, details of biocompatibility testing protocols and reports and comparative analysis.  Assume that if there is not a reputable published performance characterization of the predicate(s) you may have to do comparative side-by-side testing.  Early consultation on the verification and validation testing for your devices is now critical to ensure your submission encounters the least amount of FDA resistance to acceptance.

It is critical to good planning to understand that each submission now only has a total review time of 180 days.  Extensions beyond 180 days are no longer allowed.  If your submission is not cleared in that amount of time, FDA will stop review and withdraw the submission.  You’ll be required to resubmit and pay the additional fee for review.  The new review will not be accepted as a Special 510(k) and the full fee will be required.  The review team may change and the goal post could be moved by the time the resubmission is filed.  It is critical to do all required testing prior to submission to avoid this likelihood.  FDA will not accept an “IOU”.  Call us for details on how to ensure your submission clears!