Sec. 820.1b Scope.

(b) Limitations. The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event that it is impossible to comply with all applicable regulations, both in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.

Interpretation:

The FDA sometimes finds it beneficial to provide additional requirements for specific devices or classes of devices. Unless otherwise noted you are expected to follow QSR and the specific regulation for the device in question. If there is a conflict between some specific requirement from this regulation and the one applicable to the device – you are to follow the device’s regulation.

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Reference: www.FDA.gov

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