Does FDA Take Longer to Clear 510(k)s From Non-US Companies?

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With respect to FDA 510(k) premarket clearances, the country where the submitter is located doesn’t have any bearing on how long it takes to get clearance from the FDA. Or does it?

Using Graematter’s SOFIE System for Regulatory Intelligence, we analyzed review times for 510(k)s grouped by the contact’s location – US vs. OUS (within or outside the US) , and here’s what we found.

Note: Review times for 2014 will change as more submissions are processed through review.

This plot shows a couple of noteworthy trends:

• Average review times are trending upward – over the past decade, they have roughly doubled.
• The average review time for OUS submissions is about 15% greater than that for US submissions.

Regarding the upward trend, much has been written about the changing regulations and FDA’s budget constraints, so we will focus on the difference in review times for OUS and US submissions. First, let’s separate these into traditional and special 510(k)s.

As we might expect, traditional 510(k)s take significantly longer to clear than specials, but for both types the results show that average review times for OUS submissions are 2-3 weeks longer than those for US submissions.

This doesn’t mean that the FDA is intentionally slower in reviewing international submissions. It’s likely that there are several factors contributing to this disparity, including:

• understanding the difference between product approval and premarket clearance, and what this means in terms of the approach within the submission and the documentation required
• finding all of the appropriate guidance documents for reference
• locating the best predicate for the subject device (this is a challenge for many 510(k)s: the difference between referencing a merely sufficient predicate – perhaps an easy look toward a similar device from within your company - or referencing one that is best suited to the subject device, can mean extra rounds of questions and weeks of additional review time
• clear communication with FDA in both directions – that is, effectively compiling and communicating the necessary documentation to FDA, and also thoroughly understanding any questions from the Agency
• assessment of the competitive marketplace in terms of adverse events and recalls – if you know what are the current “hot button” issues for competitive products, you can take steps to proactively address them in your initial submission, rather than scrambling to answer unanticipated questions from the Agency

In each of these areas, it’s easy to see how an OUS submitter could be at a disadvantage. Since the best defense is a good offense, having a regulatory professional with experience in preparing successful 510(k)s is the best insurance to gaining speedy review for both US and OUS submissions.

It’s equally important to equip regulatory staff with tools that can facilitate locating an optimal predicate, appropriate guidance documents, and reviewing the competitive landscape for current issues in the field. Even the most experienced professional can get bogged down in the labyrinth of regulatory information out there, and regulatory intelligence tools can cut through the clutter to save valuable time and provide better resources. 

Crafting a complete and comprehensive submission up front will allow for shorter review times – which translates into the quickest pathway to market and the best return on your company’s investments. In Emergo’s annual medical device industry survey for 2015, regulatory issues rank just about even with financial concerns as the greatest challenges faced by senior management. Regardless of where they’re located, companies need every regulatory advantage they can get.

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.