21 CFR 820.181 - Device Master Record (QMSR)

What it says

A device master record must be maintained for each device type, containing or referencing device specifications, production process specifications, quality assurance procedures and specifications, packaging and labeling specifications, and installation, maintenance and servicing procedures.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The device master record functions as the device-side equivalent of a master production and control record, serving as the approved reference specification that every actual device history record is meant to demonstrate compliance with.
• This record can reference other controlled documents rather than containing every detail directly, provided the reference structure is clear and those referenced documents are themselves properly controlled.
• Keeping the device master record current as the approved baseline is essential, since every device history record's value depends on accurately demonstrating conformance to whatever the device master record specified at the time of manufacture.

What FDA inspectors look for

• Whether the device master record is current, complete and accurately reflects the actual approved device design and manufacturing process.
• Whether device history records can be traced back to the specific version of the device master record in effect at the time of manufacture.
• Whether changes to the device master record went through appropriate document control and design control processes before implementation.

Related regulations