Twice as many in half the time: the FDA speeds up device approvals
In the end 2017 fell short of expectations. At the half-year point the data suggested that last year might yield more US device approvals than any previous year, but in fact, with 50 devices getting the FDA’s endorsement, 2017’s total fell just shy of 2015’s.
Still, this is not a shabby showing by any means, and there is another reason for cheer in the medtech industry: these 50 products were approved faster than ever before. It took the agency an average of just 14 months to process the applications, around half the time it took in 2013 and shaving five months off the previous year’s average approval time (see analyses below).
The graph above shows a clear, though hardly smooth, increase in the annual number of FDA approvals over the past decade. It counts the number of first-time premarket approvals (PMAs), the type of marketing permission the FDA grants for high-risk devices unlike anything yet approved, and human device exemptions (HDEs), which are awarded to similarly innovative products for rare conditions.
The FDA has long struggled to find a balance between ensuring that crucial devices reach patients and denying approval to dangerous or ineffective products. Perhaps surprisingly given the US’s reputation for being friendly to big business the FDA is more stringent than European regulators, who tend to insist on safety but not always efficacy.
The poster child here is renal denervation; several of these systems were CE marked in Europe before a more rigorous FDA-mandated efficacy trial indicated that the technique did not in fact work (Failure of Medtronic’s Symplicity trial exacerbates concerns over renal denervation, January 9, 2014).
For simplicity, the graph above displays the number of PMAs and HDEs only for therapy areas that have seen at least two approvals in a single year.
It shows that, of those devices that received a PMA or HDE last year, the largest number were in the area of cardiology, reflecting the risk inherent in developing devices for cardiovascular disorders. By contrast, more than half of de novo approvals, used for wholly new technologies that pose less of a risk to the patient, were in the area of in vitro diagnostics.
Some IVDs are high risk, however – generally either tests for life-threatening conditions or companion diagnostics that assess whether a patient will respond to a particular drug for a potentially fatal disease. They must undergo the strictest review possible to ensure their accuracy. 13 such IVDs obtained premarket approval in 2017.
|Average review times of first-time PMAs and HDEs by therapy area (months)|
|EvaluateMedTech device classification||2013||2014||2015||2016||2017|
|Anaesthesia & respiratory||61.3||18.5||-||-||16.7|
|Ear, nose & throat||-||9.5||-||-||-|
|General & plastic surgery||68.2||28.7||-||24.0||12.7|
|General hospital & healthcare supply||-||-||-||39.8||-|
|In vitro diagnostics||8.6||13.3||11.3||9.8||10.2|
|Obstetrics & gynaecology||-||-||12.9||-||11.4|
In 2017 the FDA granted more than twice as many high-risk device approvals as it did in 2013 – and it did so in half the time. The devices approved in 2017 took an average of 13.8 months to pass through the FDA’s hands, beating last year’s average of 18.1 months and 2014’s previous fastest time, 16.7 months.
And this is despite including the slowest approval of the past 20 years. The Amplatzer Post-Infarct Muscular VSD Occluder, an implant designed to repair ventricular septal defects, was filed with the FDA in June 2007 by its original developer, Aga Medical. Last January, nearly 10 years later, its inheritor Abbott Laboratories received notice of its clearance.
With the highly anomalous review time of the Amplatzer VSD Occluder removed, the average time to approval was 11.8 months. It is a real possibility that the FDA will soon get its average device turnaround time down to under a year.
|De novo clearances by year|
|Year||Number||Avg time (months)|
One way the agency has cut these approval wait times is hiving off the safer innovative products into thede novo 510(k) pathway. The number of de novos to obtain clearance each year has also shown an unsteady but unmistakable increase, with this year’s total of 31 setting a new record.
Concerns have been raised in the past that efforts to increase the throughput of devices might lead to rushed, insufficient assessments. But it still takes around three years longer to obtain FDA approval for an innovative medical device than it does to get European approval, since the agency generally requires larger, better controlled clinical trials than its counterparts across the Atlantic.
The agency’s performance in recent years would seem to suggest that there has been room to liberalise without becoming dangerously lax.