Food and Drug Administration, HHS

When a requirement is qualified by ‘‘where appropriate,’’ it is deemed to be ‘‘appropriate’’ unless the manu- facturer can document justification otherwise. A requirement is ‘‘appro- priate’’ if nonimplementation could reasonably be expected to result in the product not meeting its specified re- quirements or the manufacturer not being able to carry out any necessary corrective action.
(b) Limitations. The quality system regulation in this part supplements regulations in other parts of this chap- ter except where explicitly stated oth- erwise. In the event that it is impos- sible to comply with all applicable reg- ulations, both in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other gen- erally applicable requirements.