Are You a Good Witch, or a Bad Witch?

Posted 26 August 2015 By Sharon DeGrove Bishop, RAC

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Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a good witch, or a bad witch?” As we soon learn in the film, this is a critical distinction—Glinda helps Dorothy return home to Kansas, while the Wicked Witch of the West uses every resource she has, including those terrifying flying monkeys, to capture Dorothy and her ruby slippers. We considered this question relative to the Refuse to Accept Policy for 510(k)s from the US Food and Drug Administration (FDA).

Background

In 2012, FDA revised its Refuse to Accept (RTA) Policy for 510(k) premarket clearances to add a provision for an initial “go/no-go” assessment of each new submission. Under this revised policy, FDA began conducting an early review of every 510(k) against specific acceptance criteria and committed to informing the submitter within the first 15 days whether it considers the submission to be administratively complete and therefore ready to undergo review, or if not, to identify the missing elements.

FDA’s intent in undertaking this initial acceptance review strategy was to help both industry and FDA. As stated in the guidance, “The goal of this guidance document is to clarify the content needed in traditional, special, and abbreviated 510(k) submissions to allow FDA to conduct a substantive review, thereby enhancing the quality of received 510(k) submissions and improving overall review time.”

Question

In recent days, the FDA issued a new draft of the policy that provides some clarification along with updated references and links. These will likely be helpful, however the current concern within industry dates back to the 2012 addition of the initial 15-day acceptance review process and whether it increases review time rather than improves it.

So we wanted to know—is the acceptance review process a good witch, or a bad witch?

Analysis

Using the SOFIETM System for regulatory intelligence by Graematter®, we analyzed the review times for Traditional 510(k)s to see what effect, if any, this change caused over time. Average review times (referenced by date of submission) were plotted for each quarter from 2010 through the first half of 2014* to view trends from the time before the guidance was published until after it was finalized.

We looked at all traditional 510(k)s cleared during this period, and to see the effect within particular specialties, we also broke out three of the areas with the greatest number of these submissions—orthopedic, ophthalmology, and gastroenterology-urology.

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Analysis and Conclusion

Looking at these data we see that after the RTA guidance was issued there was an increase in average review times, presumably while industry adjusted to the change. But after a brief period, average review times trended downward again and are continuing on a downward trajectory. So FDA’s intention of minimizing review times has indeed been realized. In spite of all the complaining from industry, it turns out that the RTA strategy is a good witch.

Those of us in industry should remember that we don’t like receiving incomplete reports that we have to send back for more work before we can review them. We can’t do our jobs effectively and efficiently that way, and neither can FDA.

The evidence shows that industry adapted to this change and review times have come down to where they were beforehand, indicating that industry can do and has done a better job in getting more complete submissions to FDA. And this policy gives those of us in regulatory an opportunity to require complete information from our organizations before filing, reducing the pressure to meet deadlines without regard to the quality of the information submitted.

We can view the RTA policy as support for our desire to send in the best submissions we can. Maybe it’s not a witch at all. Maybe it’s really the Wizard.

* Note that review times for 2014 may change as submissions still undergoing review are cleared.

Let us know what you think. To contact us with your thoughts or to request more information, email asksofie@graematter.com or connect with us on LinkedIn, Twitter and Facebook.

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Categories: Medical Devices, Submission and registration, Articles, News, US, CDRH

Tags: US Food and Drug Administration, FDA, medical device, refuse to accept policy, RTA, 510(k), premarket clearance

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