Submitted by kBLASTER Team on
by Sharon DeGrove Bishop, RAC, for RAPS.org
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?
Note: Review times for 2014 will change as more submissions are processed through review. Average review times are trending upward – over the past decade, they have roughly doubled. The average review time for Outside-of-US (OUS) submissions is about 15% greater than that 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:
- 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
- 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.
Go to kBLASTER to FDA 510(k) search for a primary predicate, multiple predicates or reference devices, and harness kBLASTER's uniquely effective result management features, so you can quickly build a successful 510(k) clearance strategy.