It’s tough enough getting a 510(k) through a smooth and timely FDA review. But many manufacturers discover to their cost a trap for the unwary right inside the FDA front door. FDA has since the early 1990’s screened 510k submissions for completeness. This policy was tightened in 2012 – requiring that applications pass a detailed screen before acceptance for review.
With rejection rates at times almost 60% it’s essential that anyone contemplating a 510(k) submission follows the requirements – to the letter.
Now FDA has updated it’s Refuse to Accept Guidance. The new version contains updated check lists for new, special and abbreviated 510(k) submissions. There are numerous small changes including both additions and deletions of specific criteria. The guidance now explicitly allows applicants to state (with justification) that a particular option or requirement is not applicable. Yes – this process is that specific and particular.
The Refuse to Accept screen is meant to be an administrative process by which the submission is screened for completeness. The majority of rejections have been because of absence of biocompatibility or shelf life information. FDA expects that if such information is not required, then a justification be provided. If it’s not there and there’s no explanation – FDA will reject.
The guidance clearly states that the screener should ascertain the presence of an explanation and justification for any missing elements, and not consider the adequacy of such a justification. The problem is that sometimes the presence of multiple elements of information can be interpreted as essential to proving adequacy. Consider a biocompatibility review. If there aren’t tests addressing all parts of the FDA G95-1 biocompatibility guidance, it can be argued that sufficient information is not present. But what if the manufacturer is arguing a risk management case based on pre-existing information and has not conducted new testing? It all comes down to interpretation and it’s easy to see how the lines between screening and substantive review can be blurred. If the manufacturer is relying on risk assessment and predicate device information to justify safety rather than testing – there needs to be a very clear and prominent statement to that effect which includes an explicit declaration to the effect that the associated risk analysis justifies absence of testing.
The Refuse to Accept screen doesn’t count towards formal agency review times. High failure rates are in effect a mechanism for FDA to weed out unsatisfactory applications. The theory is that sub-par submissions take up disproportionate amounts of reviewer time, and weeding them out before review improves the 510(k) review timelines. It’s also an effective choke point at the beginning of the review pipe. 60% failure rates certainly should reduce reviewer workload and contribute to improving FDA’s performance statistics.
The new guidance comes into effect on 1 October 2015. It certainly clarifies things in many ways and includes lots of fine tuning of those extensive check lists. But they are long (the traditional 510(k) checklist is 24 pages long) and it’s essential to get it all right. Just one slip and the whole submission is rejected, and there’s no limit to the number of cycles of failure…
Need assistance preparing a 510(k) – or a pre-submission consultation with FDA? Contact us for a confidential discussion about the dealing with FDA processes and how we can assist you to achieve a smooth review process..