FDA conducted 2,952 inspections of medical device manufacturers last year, making 2017 a high watermark for the agency. The figure marks a 46% rise in total inspections since 2007, driven by a 243% surge in the number of visits FDA staff paid to foreign enterprises.
The agency stepped up its oversight of medical device companies based overseas as part of its move toward a more risk-based approach to the identification of quality failings.
The Medical Device Single Audit Program (MDSAP) pilot program also contributed to increased oversight, according to an FDA report. Between 2013 and 2017, the agency received and classified nearly 600 MDSAP audits.
FDA's medical device team now oversees a vast, global industry. More than 21,000 manufacturers in 106 countries are registered with FDA, meaning the agency's staff have to venture far beyond the U.S. to ensure the quality of medical devices sold in the country.
The importance of inspecting foreign manufacturers is further increased by evidence that "quality system issues are more likely to occur in firms located overseas," Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement. That evidence has driven a shift in how Shuren's team approaches its task.
"Today's report also highlights results from a pilot initiative we launched this year using a third-party system to provide an assessment or appraisal of a firm to determine if there are any gaps in manufacturing processes or quality systems," Shuren said. "This appraisal program is designed to improve manufacturing quality and processes and has led to 32 appraisals involving 18 manufacturers who reported overwhelmingly that the appraisal had a positive impact on the quality of their devices.
FDA laid out its reasoning for the shift and its consequences in a report about the enforcement of medical device regulations. The report shows FDA stepped up its oversight of medical device facilities between 2008 — when it conducted fewer than 2,000 inspections — and 2010. The number of FDA inspections hovered just above 2,500 in the years following 2010, before jumping again last year. The number increased despite FDA receiving 600 reports via a single audit program from 2013 to 2017.
The risk-based rationale that led FDA to inspect more foreign manufacturers has also influenced the types of medical devices it targets. In the report, FDA presents three case studies detailing why it went after certain sectors.
For example, FDA responded to the 56,000 adverse event reports it received about infusion pumps from 2005 to 2009 by setting out to improve the devices. From 2010 to 2017, FDA performed 496 inspections of 165 infusion pump manufacturing facilities. The flurry of activity led to 40 warning letters and, ultimately, to an 82% decline in annual medical device reports since 2015.
The report does not attempt to quantify the effect of these changes on patient safety, but does offer evidence that FDA's actions are encouraging manufacturers to initiate and report recalls. Since 2009, FDA has seen a 50% increase in the annual number of reported voluntary medical device recalls.
Editor's note: A previous version of this story misstated the time period during which the rise in total inspections occurred. The 46% rise in total inspections has occurred since 2007.