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Medical Device Inspection Contract Program

Medical Device Inspection Contract Program

What is the Medical Device Inspection Contract Program?

This program funds the inspections of Class I and Class II medical device manufacturers to determine compliance with the FDA's Guide to Inspections of Quality Systems (QSIT) and good manufacturing practice (GMP) regulations.

Which states currently have a contract?

United States Map displaying two (2) FDA funded medical device inspection contract states: CA, TX

United States Map displaying two (2) FDA funded medical device inspection contract states: CA, TX

  • Two (2) contracts with state government regulatory agencies.
  • Two states are covered under this contract program.

Where can I find more information?

You can review the FDA's Guide to Inspections of Quality Systems here.

For more information, you can review Section 510 (h) of the Federal Food, Drug and Cosmetic Act.

Specific questions on this program can be directed to the appropriate Office of Partnerships' contact within the Division of Partnership Investments and Agreements. Please visit the Office of Partnerships Contacts webpage to obtain a downloaded version of the staffing roster. 

General questions may be directed to Office of Partnerships' general mailbox: op.feedback@fda.hhs.gov.