21 CFR 820.65: Traceability
Required manufacturers of surgical implants and life-sustaining devices whose failure could cause significant injury to establish procedures assigning control numbers to each unit, lot, or batch (and components where appropriate), documented in the DHR, to facilitate corrective action.
Part 820, Quality System Regulation · Subpart F, Identification and Traceability
Most device 483s cite the Quality System Regulation in force before February 2, 2026, when the QMSR replaced it. Those sections are marked Former.
How FDA words it
The opening lines investigators use most when they cite 820.65, from the 483s we hold.
Procedures for identifying with a control number each unit, lot, or batch of implantable or life supporting, life sustaining finished devices or appropriate components have not been adequately established.Most used
Recent 483s citing 820.65
- Ad-Tech Medical Instrument Corporation · Oak Creek, WisconsinProcedures for identifying with a control number each unit, lot, or batch of… Jun 27, 2019
- Buffalo Dental Manufacturing Co., Inc · Syosset, New YorkProcedures for identifying with a control number each unit, lot, or batch of… Dec 22, 2015
- Biodex Medical Systems, Inc · Shirley, New YorkProcedures for identifying with a control number each unit, lot, or batch of… Mar 18, 2015
The regulation text
§ 820.65 Traceability. As published before it was replaced.
Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.
Questions
What does 21 CFR 820.65 require?
Required manufacturers of surgical implants and life-sustaining devices whose failure could cause significant injury to establish procedures assigning control numbers to each unit, lot, or batch (and components where appropriate), documented in the DHR, to facilitate corrective action.
How do FDA investigators word a 820.65 observation?
The most common opening is: “Procedures for identifying with a control number each unit, lot, or batch of implantable or life supporting, life sustaining finished devices or appropriate components have not been adequately established.”
Which sections are cited alongside 820.65?
In the same 483s, investigators most often also cite 820.100 (Corrective and preventive action), 820.120 (Device labeling), 820.184 (Device history record), 820.40 (Document controls).