US FDA
21 CFR 820.170 - Installation (QMSR)
Plain-language explanation, inspection context and common violation patterns.
What it says
Where a device requires installation, adequate installation and inspection instructions must be established and maintained, with installation and inspection performed according to those instructions, and records of installation kept demonstrating conformance to specifications.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- This provision extends device quality system obligations beyond the manufacturing facility to the actual point of use, recognising that a device correctly manufactured but incorrectly installed can still fail to perform as intended.
- Installation instructions must be specific enough to actually be followed correctly by the person performing installation, whether that is the manufacturer's own personnel, a distributor or the end user.
- Installation records create the same kind of traceable evidence for the installed device that the device history record creates for manufacturing, extending accountability through to actual deployment.
What FDA inspectors look for
- Whether installation instructions are sufficiently clear and specific to be reliably followed by their intended audience.
- Whether installation records are actually generated and retained, demonstrating conformance to specifications at the point of installation.
- Whether installation performed by a third party, such as a distributor, is verified as following the manufacturer's actual instructions.
Most common violation
Installation instructions that are technically accurate but not validated for clarity and usability by the actual personnel expected to perform installation in real-world settings.
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