Which of the following statements about 3rd party establishment inspections under MDUFMA is NOT true?

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Multiple Choice

Which of the following statements about 3rd party establishment inspections under MDUFMA is NOT true?

Under MDUFMA, third-party establishment inspections involve FDA-recognized third parties (accreditation bodies) auditing foreign manufacturers to assess compliance with the Quality System Regulation. Eligibility isn’t dictated by device class; it’s about meeting criteria like market presence and FDA inspection history, plus FDA approval of the chosen inspection organization. The statement that manufacturers of class III devices are ineligible is not true because device class does not automatically exclude a manufacturer from 3rd-party inspections. If the other eligibility requirements are met (marketing at least one device in the US and in foreign markets, FDA-approved third-party inspector, and recent FDA inspection results that are NAI or VAI), Class III manufacturers can participate. The other criteria—a device being marketed in both the US and foreign markets, recent inspection outcomes being NAI or VAI, and notifying FDA of the chosen inspection person for approval—are consistent with how the program operates.

Under MDUFMA, third-party establishment inspections involve FDA-recognized third parties (accreditation bodies) auditing foreign manufacturers to assess compliance with the Quality System Regulation. Eligibility isn’t dictated by device class; it’s about meeting criteria like market presence and FDA inspection history, plus FDA approval of the chosen inspection organization.

The statement that manufacturers of class III devices are ineligible is not true because device class does not automatically exclude a manufacturer from 3rd-party inspections. If the other eligibility requirements are met (marketing at least one device in the US and in foreign markets, FDA-approved third-party inspector, and recent FDA inspection results that are NAI or VAI), Class III manufacturers can participate.

The other criteria—a device being marketed in both the US and foreign markets, recent inspection outcomes being NAI or VAI, and notifying FDA of the chosen inspection person for approval—are consistent with how the program operates.

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