510(k) Statistical Patterns

The majority of new medical devices reviewed by FDA enter the market via the 510(k) process. In 2013, FDA cleared approximately 140 510(k)s for every original PMA application approved.

For most medical device companies, it is critical to understand the 510(k) process, evaluate the likelihood of success, and maximize the odds of obtaining clearance. In particular, companies must answer two commercially critical questions:

How long will the process take?

What is the likelihood of success?

As mandated by MDUFA III, FDA calculates and publishes some 510(k) statistics that help make these predictions, including average time to decision and the percent of 510(k)s with additional information requests. These documents provide high-level data on key metrics for a particular fiscal year, but a major limitation is that the calculation of averages will mask product-specific or classification-specific variations. However, the agency has also released information-rich databases that enable far more probing analyses than were previously available. These databases can help companies identify trends that affect timing and odds, and, perhaps, help companies improve the chances of a successful 510(k).

In the book Moneyball, author Michael Lewis explained how the Oakland Athletics exploited new insights derived from statistics to gain an edge in baseball. In the intervening years, baseball sabermetricians have developed esoteric statistics, such as wins above replacement (WAR), that most fans do not understand but which are considered more meaningful indications of a player’s value than runs batted in or batting average. The sabermetricians now have new, more comprehensive data sources available, allowing for yet more refined analysis.1

While 510(k)s and baseball may seem to have little in common (except for the authors’ keen interest in both), they share a common trait: New analytical tools can yield useful insights. In that spirit, we have analyzed the 510(k) program in a new light. Using SOFIE, Graematter Inc.’s Regulatory Intelligence System, we analyzed various 510(k) metrics from FDA’s publicly available 510(k) Premarket Notification Database during the five-year period from 2008 to 2012 to gain insights about this primary pathway to market for medical devices.

Additional information available here.