Rework

Rework follows documented instructions, and the reworked product is checked again against the requirements. Under ISO 13485, which the FDA's QMSR now incorporates, the possible adverse effect of rework on the product has to be considered and recorded.

Rework means action taken on a nonconforming product so that it will fulfill the specified requirements in the medical device file (MDF) before it is released for distribution. Safety and Performance shall have the meaning of “safety and effectiveness” in Clause 0.1 of ISO 13485. The phrase “safety and performance” does not relieve a manufacturer from any obligation to implement controls or other measures that provide reasonable assurance of safety and effectiveness.

21 CFR, 820.3