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Is a Factory Inspection Required for FDA Registration in the United States?
Category：行業(yè)資訊 Date：2024-11-15 17:02:33 Author: Source:
If you're applying for FDA registration, it’s essential to ensure that your facility adheres to FDA’s standards even if an inspection isn’t initially required.

Yes, a factory inspection is typically required for FDA registration in the United States, but it depends on the type of medical device and the circumstances.

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For certain high-risk devices (Class II or Class III), the FDA may conduct a facility inspection as part of the premarket approval process (PMA or 510(k) submission). The inspection helps ensure that the manufacturing facility complies with the FDA’s Good Manufacturing Practice (GMP) regulations, known as the Quality System Regulation (QSR).

For lower-risk devices (Class I), an inspection is not always required, but the FDA may still inspect facilities during routine surveillance or if concerns arise.

If you're applying for FDA registration, it’s essential to ensure that your facility adheres to FDA’s standards even if an inspection isn’t initially required.

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