The FDA has been inspecting more and more medical device manufacturers over the past 5 years, and that's resulted in an 8-year peak in warning letters issued, according to a study.
The agency conducted 2,087 medical device inspections last year, according to regulatory compliance outfit Emergo Group, a 47% jump over 2008's 1,423. That resulted in a more dramatic leap in warning letters issued, spiking 67% over the same period to 164 in 2012.
And the FDA's amped-up surveillance has thus far focused mostly on manufacturing--not design, management or document control. Emergo notes that 60% of warnings handed out last year cited companies for failures in corrective and preventative action or production and process controls.
"Medical device firms should expect the trend of stepped-up FDA inspections to continue through the Obama Administration's second term," Emergo writes, adding the agency has made clear to manufacturers that it will be keeping a close eye on quality systems.
The FDA has hardly suggested that it plans to slow down. The agency is requesting $870 million to run the Center for Devices and Radiological Health next fiscal year, an 11% year-over-year increase that would in part fund an expansion of the department's inspection capacity.
- check out Emergo's analysis