A recent report published by consulting company Emergo Group shows that review times for 510(k) submissions improved slightly in 2011, but remains close to the record highs seen in 2010 that have upset many in industry.
Emergo's report, An Analysis of US FDA 510(k) submissions received between 2006 and 2011, tracks statistics associated with 510(k) premarket notification submissions. Under FDA regulations, companies intending to market a device that is substantially equivalent to an already-approved predicate device must notify the agency at least 90 days in advance of marketing the product.
But just proving substantial equivalence can be difficult, and regulators have been seen as wary in recent years to approve some products in the wake of notable lapses in safety. Metal-on metal hip implants, defibrillator leads, heart valve rings and vaginal mesh products have all been associated with serious safety concerns, and all were cleared by FDA via the 510(k) pathway.
As those concerns have mounted, the number of 510(k) submissions approved by FDA each year has plummeted compared to the number of products cleared just five years ago. In 2006, FDA managed to clear 3,325 510(k) submissions, the report notes. The year after, just 3,068-a 7.7% decrease in just a single year.
Since then, that decrease has become the new baseline for approvals. In 2008, FDA cleared 3,134 devices; 3,104 in 2009; 2929 in 2010; and 3,055 in 2011.
2011's clearance number might stand to rise between 3-5% once the final batch of 510(k) submissions are cleared by FDA in early 2013, Emergo noted.
Average Review Times-Cause for Concern?
Many companies, however, haven't been as concerned about the number of 510(k) submissions cleared by FDA as the time it takes, on average, for them to receive a clearance decision. Emergo's data shows this concern is well-founded, with average clearance times increasing in five of the last six years.
The average clearance in 2006 took 97 days, the report shows. By 2010, that time has increased by 50% to 146 days on average. While 2011 saw a slight improvement (138 days on average), that could be cold comfort for an industry that has long complained that delays are jeopardizing its returns on investment and ability to innovate.
Not all devices, it should be noted, are created equal. A radiology device takes 79 days on average to clear-by far the shortest time of all devices assessed by Emergo. The next fastest device category was cardiovascular devices, which were cleared in 105 days on average. At the other end of this spectrum were immunology devices, which took 201 days on average to clear, and pathology devices, which ranked worst at 204 days to clear on average.
One reason behind those averages might be economies of scale. Devices that constituted the highest percentage of 510(k) submissions tended to have the smallest average number of calendar days from submission to clearance. Orthopedic devices, which constituted 15.8% of all devices, took just 115 days on average to approve. Clinical toxicology devices, which constituted 1.3% of all 510(k) submissions, took third-longest at 185 days on average.
The top 20 most common medical devices all took below 120 calendar days on average to obtain clearance, the report notes.