21 CFR Part 807 - Establishment Registration and Device Listing

What it says

Owners and operators of establishments that manufacture, prepare, propagate, compound or process a medical device must register their establishment with FDA and list the devices they make, keeping this information current on an annual basis.

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

What it means in practice

• Registration and listing is a baseline administrative obligation, but FDA also uses the registered establishment list to prioritize and schedule quality system inspections, so an inaccurate listing can misdirect or delay an inspection.
• A device manufacturer that contracts out manufacturing steps still needs to correctly identify which entity, itself or the contractor, holds the registration obligation for each activity performed.
• Failing to register or list is treated as a distinct compliance gap from quality system failures, meaning a facility can have a compliant quality system and still be out of compliance on registration.

What FDA inspectors look for

• Whether the establishment's registration and device listing information matches what is actually being manufactured at the site during the inspection.
• Whether new devices, or new manufacturing activities added at the site since the last listing update, have been reflected in an updated listing.
• Whether contract manufacturing relationships are correctly reflected in registration records, so responsibility for a given manufacturing step is clearly assigned.

Related regulations