FDA medical device establishment inspections worldwide 2009-2019

This statistic shows the number of inspections the Food and Drug Administration (FDA) made of domestic and foreign medical device establishments from FY 2009 to FY 2019. For FY 2019, estimates say that the FDA inspected almost 2,500 medical device establishments.

Total number of inspections of medical device establishments by the FDA from 2009 to 2019*

Fiscal yearNumber of inspections
2019**2,498
20182,550
20172,648
20162,621
20152,663
20142,619
20132,759
20122,637
20112,523
20102,448
20091,978
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Source

Release date

September 2019

Region

United States

Survey time period

FY 2009 to FY 2019

Supplementary notes

* Including domestic and abroad device establishment inspections.
"Any establishment where devices are manufactured, processed, packed, installed, used, or implanted or where records of results from use of devices are kept, can be subject to inspection."
Domestic and Foreign data consist of Bioresearch Monitoring Program Inspections, Pre-Market Inspections, Post-Market Audit Inspections, and GMP Inspections.
The statistic was assembled from several FDA reports.

** Estimate.

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