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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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Regulatory News | 19 February 2015 | By Sharon DeGrove Bishop, RAC
Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at email@example.com
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:
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:
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.
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Tags: RIQ, Regulatory Intelligence Quotient, Graematter, 510(k), Special 510(k), Traditional 510(k), Clearance, Premarket Notification