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Medical Device Inspection Contract Program

Medical Device Inspection Contract Program Fact Sheet (Version October 2023)

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?

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.
  • $241,464.60 in funding 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.

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