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Medical Devices / Inspections and Audits

FDA Officials Show Support for Risk-Based CAPA Strategy

Sept. 21, 2017
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FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique.

EduQuest, a company founded by former FDA investigators, created a framework that divides CAPAs into three levels of risk. The first level is for nonconformities that “could lead to death, serious injury or illness,” the second is for those that “could result in minor injuries or illnesses,” and the third is for those that present an “improbable” risk.

FDA senior advisor Carl Fischer and Adam Saltman, a medical officer at CDRH, agreed that the framework is a good baseline for ensuring timeliness with CAPAs. “I think it's very helpful to think about these things in a framework,” Fischer said.

However, each CAPA action should be independently assessed because “levels of risks are all open to interpretation,” Fischer said. He argued it is important to also consider the likelihood of harm and the severity of harm. “You can’t always go into these levels with hard differences.”

The officials were not able to say how many CAPAs at one time would be considered too many, but said a large number of open CAPAs is likely to suggest a problem.

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