FDA medical device establishment inspections worldwide 2009-2023

Total number of inspections of medical device establishments by the FDA from 2009 to 2023*

Loading statistic...
Show detailed source information?
Register for free
Already a member?
Log in

Use Ask Statista Research Service

Release date

March 2023


United States

Survey time period

FY 2009 to FY 2023

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
Statista Accounts: Access All Statistics. Starting from $1,788 USD / Year
Basic Account
Get to know the platform

You only have access to basic statistics.

Starter Account
The ideal entry-level account for individual users
  • Instant access to 1m statistics
  • Download in XLS, PDF & PNG format
  • Detailed references
$149 USD / Month *
Professional Account
Full access

Business Solutions including all features.

* Prices do not include sales tax.

Other statistics that may interest you Pharmaceutical and medical device recalls in the U.S.



Pharmaceutical product recalls


Digression: pharmaceutical violations


Medical device recalls


Medical devices- inspections and warnings


Further related statistics

Statista Accounts: Access All Statistics. Starting from $1,788 USD / Year
Learn more about how Statista can support your business.