510(k) Clearances at 5-Year Low: Report

The Medical Alley Association, which advocates for Minnesota healthcare industry companies and individuals, says that 510(k) clearances declined 26% in 2015 to their lowest point in five years. At the same time, it says, comparable clearances outside the U.S. rose 51%. The group’s annual approval report also says that globally, Minnesota companies lead the list of recipients of 2015 medical device approvals and clearances.

There were 3,060 510(k)s cleared worldwide, the association says, with an average clearance time of 152 days. The U.S. had two-thirds of the clearances. The top subsectors were orthopedics (621), cardiology (324), diagnostic imaging (284), and dental (239).

Some 45 original PMAs were approved last year, a 55% increase from 2014 and the highest number of approvals in a decade. The U.S. had 44 of the 45 approvals. The average approval time was 489 days, and the top subsectors were cardiology (14), in vitro diagnostics (10), orthopedics (6), and neurology (5).

Worldwide, 2,116 supplemental PMAs were approved, 93% of which were in the U.S. The average approval time was 75 days, and the leading subsectors were cardiology (1,119), in vitro diagnostics (186), neurology (162), and orthopedics (100).

The report says that Asia and Europe drove the spike in 510(k) clearances outside the U.S.

Looking at a new FDA initiative, the report says that the recent agency strategic priority to increase the number of early feasibility studies (EFS) conducted in the U.S. resulted in dramatic increases in IDE approvals based on the studies. “One of the big trends facing FDA in 2016 is the continuing increase of EFS IDE submissions in the U.S. and how approval rates can improve…. It is reasonable for medical device manufacturers to expect FDA to continue improving the EFS submission process, which may continue to increase the number of studies conducted in the U.S. As the number of EFS submissions increases, FDA review divisions continue to gain additional experience with the EFS program…. Another aspect of FDA’s focus may be on submission quality.”

Given the Medical Alley Association’s focus on Minnesota companies, the report notes that the top three recipients of approvals and clearances were Medtronic, Boston Scientific, and St. Jude Medical, which together accounted for 22% of all clearances and approvals worldwide in 2015. It says that the top 10 Minnesota companies made up over one-third of all clearances and approvals.