An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
3. IDENTIFICATION AND TRACEABILITY
The identification and traceability sections of the quality system regulation (subpart F) impose almost no new requirements for device manufacturers. But the agency had floated several possibilities as part of the 1995 working draft, and manufacturers should be aware of the outcome of subsequent discussions.
Identification (820.60). The new regulation's section on identification requires manufacturers to properly identify product through all stages of production, distribution, and installation (when applicable). This is a requirement that FDA has always enforced and is included in the 1978 GMP regulation (820.80 and 820.100). No changes have been made in this requirement since the 1995 working draft was published.
Traceability (820.65). The section on traceability sets forth the same requirements as those contained in the 1978 GMP regulation; that is, only critical devices are subject to traceability requirements. However, the new regulation does not use the same wording as was proposed in the 1995 working draft. While the regulation does not say that traceability applies to critical devices, the description of the devices subject to traceability reads the same as the definition of critical device contained in the 1978 GMP regulation (820.3(f)). The November 1993 proposal contained the same requirements, but the 1995 working draft was revised to include all components and finished devices when necessary to protect the public health. This was a very subjective requirement that would have greatly broadened the range of devices subject to traceability. It's good to see that FDA has returned to the original concept of requiring traceability only for critical devices.
The new section also says that components are subject to traceability "where appropriate." Manufacturers of critical devices that have previously provided rational, documented criteria for identifying critical components should be able to meet this requirement without any additional effort.
Basically, these requirements should not require any industry change, because manufacturers of critical devices are already subject to the critical device and critical component traceability requirements of the 1978 GMP regulation.
