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