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 2020. For FY 2020, estimates say that the FDA inspected over 2,500 medical device establishments.
Total number of inspections of medical device establishments by the FDA from 2009 to 2020*
* 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. (May 26, 2021). Total number of inspections of medical device establishments by the FDA from 2009 to 2020* [Graph]. In Statista. Retrieved August 08, 2022, 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 2020*." Chart. May 26, 2021. Statista. Accessed August 08, 2022. https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/
Food and Drug Administration. (2021). Total number of inspections of medical device establishments by the FDA from 2009 to 2020*. Statista. Statista Inc.. Accessed: August 08, 2022. 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 2020*." Statista, Statista Inc., 26 May 2021, 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 2020* Statista, https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/ (last visited August 08, 2022)
