The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report.
“As medical device manufacturing has become an increasingly global enterprise, the FDA has taken forceful action to increase inspections of medical device firms, especially those located in foreign countries,” said
Jeff Shuren, director at the FDA’s Center for Devices and Radiological Health (CDRH). “Our increased oversight has led to tangible results with improved compliance.”
CDRH’s medical device enforcement and quality report
—issued on Wednesday—attributes the increase in international oversight across 106 countries over the past decade to a new approach in quality management system compliance involving the Medical Device Single Audit Program (MDSAP) developed via the International Medical Device Regulators Forum (IMDRF).
CDRH began accepting MDSAP audit reports last year, following a three-year pilot of the ISO 13485-based program that confirmed its viability from 2014 through 2017. “In addition to the device inspections conducted by the FDA, we received and classified nearly 600 MDSAP audits from 2013 to 2017,” CDRH’s new 9-page report states. MDSAP is intended to aid compliance with requirements across multiple jurisdictions to reduce regulatory burden via a single audit.
The annual number of US medical device inspections also increased by 46% over the same time period, totaling 2,952 inspections in 2017. The report marks the largest annual number of FDA-conducted device inspections, both internationally and domestically, since 2007 figures.
In addition to the MDSAP trend, the report speaks to a shifting mindset among investigators to employ a “targeted, risk-based approach to address specific device areas of concern.” It provides new figures on device-specific inspections as well. These include infusion pumps, with a total of 496 inspections conducted and 40 warning letters issued between 2010 and 2017.
Agency investigators are also putting a larger emphasis on firms’ compliance with requirements on reporting device deficiencies under 21 CFR Part 806 while conducting site inspections. This focus on “industry correction and removal compliance has contributed to a 50% increase in the annual number of voluntary recalls reported since 2009,” according to the report.
CDRH added it has implemented a “more aggressive approach” to issuing warning letters by limiting these to firms “who have severe violations or who fail to implement or follow-through on their corrective action plan in a timely fashion,” while at the same time taking a “more interactive approach” with all other nonconforming firms. This, in turn, has resulted in 82% of firms that were found to have corrected good manufacturing practices violations between 2008 and 2017.
New figures on CDRH’s 2011 Case for Quality program were provided as well, with participants reporting the appraisal model to have a positive impact on the firm and on product quality.