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 2024. For FY 2024, the FDA inspected over 2.4 thousand medical device establishments.
Total number of inspections of medical device establishments by the FDA from 2009 to 2024*
* 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. (April 9, 2024). Total number of inspections of medical device establishments by the FDA from 2009 to 2024* [Graph]. In Statista. Retrieved December 21, 2024, 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 2024*." Chart. April 9, 2024. Statista. Accessed December 21, 2024. https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/
Food and Drug Administration. (2024). Total number of inspections of medical device establishments by the FDA from 2009 to 2024*. Statista. Statista Inc.. Accessed: December 21, 2024. 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 2024*." Statista, Statista Inc., 9 Apr 2024, 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 2024* Statista, https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/ (last visited December 21, 2024)
Total number of inspections of medical device establishments by the FDA from 2009 to 2024* [Graph], Food and Drug Administration, April 9, 2024. [Online]. Available: https://www.statista.com/statistics/618755/fda-medical-device-establishment-inspections-worldwide/
