FDA Medical Device Quality Inspections Drop in 2015

The U.S. Food & Drug Administration (FDA) has released statistics showing that it inspected fewer medical device manufacturers in 2015 than in 2014.

A roundup of the FDA’s Quality System program for 2015 shows 2,104 inspections, compared to 2,213 in 2014, a decrease the FDA calls “slight[].” The Quality System program began in the mid-1990s and is designed to ensure ongoing safety and quality in the design, manufacturing, packaging, labeling, storing, and servicing of medical devices. The FDA can inspect facilities used by medical device manufacturers as ucm218078well as issue warning letters to potentially non-compliant manufacturers under the regulation.

Despite the drop of around 5% in inspections overall, inspections of non-U.S. manufacturers rose from 594 in 2014 to 620 in 2015. China and Germany accounted for most of the foreign inspections, with 126 and 90 respectively. No other country had more than 50 inspections last year. The FDA noted that it has “been working toward increased foreign inspections as foreign manufacturer inventory has been growing rapidly.”

AnnualInspections(1)

The number of warning letters issued by the FDA under the Quality System program remained the same from 2014 to 2015, at 121 warning letters. The number of warning letters issued by the FDA had previously been decreasing by about 20 per year.

Chart 2

The FDA hopes that by releasing this data, industry can “improve device quality by sharing common observations from inspections” and avoid receiving warning letters.

The report was prepared by the FDA’s Center for Devices and Radiological Health, which promotes safety and innovation in the medical device field.

Nathan Reeves
Nathan Reeves is an associate in our Seattle office. He practices intellectual property law, with an emphasis on litigation. Mr. Reeves received his Bachelor's degrees from Walla Walla University, where he also conducted research in materials science. Mr. Reeves received his J.D. from Harvard Law School, where he worked as a clinical intern in the school's Cyberlaw Clinic and as Managing Editor of the Harvard Journal of Law & Public Policy. Mr. Reeves joined the firm in 2015. He has experience representing clients in fields ranging from software and web services, to satellite communications, to media and entertainment.
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