Home News & Events News overview ‘Overseas’ inspections of medical device firms by the FDA: Are you on FDA’s hit-list?

Joris Bannenberg

CMO & Medical Director

January 24, 2019

‘Overseas’ inspections of medical device firms by the FDA: Are you on FDA’s hit-list?

In a recent ‘FDA in Brief ’ report, the agency highlights how more inspections of medical device manufacturers and a targeted risk-based approach have led to improved compliance.

In recent years the FDA has taken forceful action to increase its inspections of medical device firms, especially those overseas. “Over the past decade, we’ve increased the annual number of international device inspections by 243% taking into account that quality system issues are more likely to occur in firms located overseas,” said Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health. “Our increased oversight has led to tangible results with improved compliance.”

Following the publication of a new report – the ‘Medical Device Enforcement and Quality Report’ – Shuren highlights the results of a pilot appraisal programme launched by the FDA in 2018, where a third-party system is used to assess gaps in a firm’s manufacturing processes and quality systems. Thirtytwo assessments have involved 18 manufacturers, who reported overwhelmingly that the appraisal had a positive impact on device quality.

Other key findings in the report include the following:

  • the implementation of the FDA’s Medical Device Single Audit Program – which allows a single audit of a medical device manufacturer’s quality management system to be completed on behalf of multiple countries – has further increased the FDA’s oversight of foreign manufacturing facilities
  • the FDA has increased its oversight through additional device inspections – since 2007, the annual number of device inspections has gone up by 46% and the annual number of inspections of foreign firms has increased by 243%
  • the FDA is operating a targeted risk-based approach to addressing concerns with specific devices – when it identifies device quality or manufacturer compliance concerns, it inspects firms, takes enforcement actions as needed, collaborates with stakeholders to address contributing scientific and policy challenges, and publicly communicates to ensure transparency and reduce the chance of similar recurrent issues. The report outlines several cases where increased compliance actions and voluntary recalls have led to better compliance, improved device quality, and a reduction in reported injuries and deaths in patients. In other words, you can do your own risk-analysis if you’re on the ‘hit-list’ of the FDA!

  • 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, with new data from follow-up inspections showing that most firms have corrected their violations.

    Source: https://tinyurl.com/y78dm3qz

    Reproduced (but slightly adapted) from Advisor issue 434 dated 28 January, with the permission of the publisher, Canary Ltd, www.canarybooks.com.

    About the author

    Joris Bannenberg CMO & Medical Director

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