21 CFR 820.180 - General Requirements for Device Records

What it says

All records required under the quality system regulation must be maintained at the manufacturing establishment or a reasonably accessible location, be made readily available for review and copying by FDA, and be retained for a period equivalent to the device's design and expected life, but not less than two years from release for commercial distribution.

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

What it means in practice

• This general records provision establishes the baseline accessibility and retention standard that all the more specific device record requirements, such as device history records and design history files, must satisfy.
• Reasonably accessible location means records stored offsite or electronically must still be retrievable within a timeframe that does not obstruct an FDA inspection.
• Retention tied to expected device life, rather than a flat period, means higher-risk, longer-life devices can carry substantially longer retention obligations than simpler, shorter-life devices.

What FDA inspectors look for

• Whether required quality system records can actually be retrieved and produced promptly during the inspection, wherever they are physically or electronically stored.
• Whether record retention periods applied match the specific device's design and expected life, rather than a single default period applied across dissimilar products.
• Whether electronic record systems used to store required records maintain the same accessibility and integrity as paper records would.

Related regulations