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Total number of inspections of medical device establishments by the FDA from 2009 to 2024*

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Source

Release date

April 2024

Region

United States

Survey time period

FY 2009 to FY 2024

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.

Citation formats

FDA medical device establishment inspections worldwide 2009-2024

Published by
Conor Stewart,
Jul 9, 2024

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.

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