FDA In Brief: FDA’s increased inspections of medical device manufacturers and targeted risk-based approach leads to improved compliance

November 21, 2018

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“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. Over the past decade, we’ve increased the annual number of international device inspections by 243 percent taking into account that quality system issues are more likely to occur in firms located overseas,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Our increased oversight has led to tangible results with improved compliance. 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. 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. These efforts are another demonstration of the agency’s commitment to ensuring medical devices are safe and effective throughout the total product lifecycle.”

The FDA’s Center for Devices and Radiological Health issued a new Medical Device Enforcement and Quality Report today that details several key findings. First, the FDA has increased its oversight through additional device inspections. Since 2007, the FDA has increased its annual number of device inspections by 46 percent and has increased annual inspections of foreign firms by 243 percent. The FDA has also helped establish the Medical Device Single Audit Program to allow for the conduct of a single audit of a medical device manufacturer’s quality management system on behalf of multiple countries, which has further increased the FDA’s oversight of foreign manufacturing facilities beyond the inspections the agency performs on its own. Second, the FDA has taken a targeted risk-based approach to addressing concerns with specific devices. The report outlines several case studies of devices like infusion pumps and automated external defibrillators, where increased compliance actions and voluntary recalls have led through the years to better compliance, improved device quality, and a reduction in reported injuries and deaths in patients.

The report also details how the FDA’s focus on identifying reporting deficiencies during inspections has led to an increase in voluntary recalls and adverse event reporting. And the report highlights new data showing that most firms have corrected violations on follow-up inspections. Lastly, the FDA has taken steps to promote device quality, not just compliance, with regulations through the Case for Quality initiative that includes a voluntary quality maturity appraisal pilot launched this year.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.