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*
* 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.
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Food and Drug Administration. (September 23, 2019). Total number of inspections of medical device establishments by the FDA from 2009 to 2019* [Graph]. In Statista. Retrieved January 28, 2020, from https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/
Food and Drug Administration. "Total number of inspections of medical device establishments by the FDA from 2009 to 2019*." Chart. September 23, 2019. Statista. Accessed January 28, 2020. https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/
Food and Drug Administration. (2019). Total number of inspections of medical device establishments by the FDA from 2009 to 2019*. Statista. Statista Inc.. Accessed: January 28, 2020. https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/
Food and Drug Administration. "Total Number of Inspections of Medical Device Establishments by The Fda from 2009 to 2019*." Statista, Statista Inc., 23 Sep 2019, https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/
Food and Drug Administration, Total number of inspections of medical device establishments by the FDA from 2009 to 2019* Statista, https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/ (last visited January 28, 2020)
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