The 12%: Diagnostics “Quick Reviews” Make A Mark, FDA Official Says

The first month of the diagnostics office’s “triage” pilot program has led to quicker reviews for some 510(k)s, an agency official reports. To qualify for the program's quick-review pathway, a submission must be of high quality and free of certain time-consuming complexities.

FDA’s diagnostics office accepted 12% of 510(k)s into its new “quick-review” pathway during the pilot program's first month, according to an agency official.

The six-month “triage” pilot began April 2 with the goals of helping reviewers better manage their workloads and giving sponsors a time-to-market incentive to improve the quality of their submissions. Diagnostics reviewers plan to complete work on “quick-review” submissions within 30 days, rather than the standard 90 days for 510(k)s. (See (Also see "Regulatory News In Brief" - Medtech Insight, 23 Apr, 2012.).)

Three quick-review 510(k) submissions have been cleared – one in nine days, one in 26 days and one in 34 days.

“If industry does a good job of putting the submissions together upfront, then we can put it on a different review track, a quick-review track, where we can try to finish it in 30 days,” said Donald St. Pierre, deputy director of new product evaluation in the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD), during a May 23 webinar sponsored by the American Association for Clinical Chemistry.

OIVD expected about 10% of submissions to qualify for the accelerated review, “so we are pretty much on target,” Pierre said. Three of the quick-review submissions have been cleared, he noted, one in nine days, one in 26 days and one in 34 days.

“We will assess this after six months,” he said. “Based on the initial stats, I suspect that this will be somewhat successful.”

Assuming that is the case, the Office of Device Evaluation, which reviews all non-diagnostic devices, will likely adopt the approach, as well, St. Pierre said.

OIVD has posted a checklist online that reviewers use to assess the quality of 510(k) submissions for entry into the quick-review path. First, all required elements of a submission must be included, and second, the information must be well organized, clearly written and without significant gaps or inconsistencies, “so we can go through it quickly,” St. Pierre explained.

Also, while sponsors typically have a choice of including either a brief “510(k) statement” or a more detailed “510(k) summary” with a submission, the “summary,” which more comprehensively outlines the basis for a substantial equivalence claim, is required to qualify for a quick review.

“The intent of the quick-review process is to take advantage of the information already provided by the sponsor in the 510(k) summary and write a non-public decision memo that does not repeat this information and therefore takes less time to write,” OIVD explains on its website.

Also, a submission will only be selected for quick review if reviewers have sufficient experience with the relevant product type; if the agency determines that a time-consuming consult with an expert who works elsewhere in FDA will not be necessary; and if a CDRH database check does not uncover any unexpected post-market safety issues with related products that might warrant more detailed consideration.

St. Pierre noted that he had originally envisioned the risk level of a device, along with application quality, as primary factors in selecting devices for quick reviews, with higher risk 510(k) products less likely to be accepted. (See (Also see "FDA Dx Office Plans Pilot 510(k) ‘Triage’ Program For Early 2012" - Medtech Insight, 26 Sep, 2011.).)

But the OIVD review staff, which took the lead in designing the pilot, disagreed with that approach.

“The staff thought that the level of risk was not a key factor,” St. Pierre said. “If [a submission] is put together really well, and it is clear and well documented, you can go though that pretty quickly. ... So this is one of the few things we don’t base on risk.”