Devices

Correlating Device Inspections with Warning Letters

Attorney Bradley Thompson (Epstein Becker Green) says it is possible to use FDA data on medical device inspection observations and Warning Letters to attempt to determine which observations might lead to Warning Letters. In a detailed online post that goes through the methodology he used as a regulatory data scientist, Thompson says that his findings represent only a correlation and not necessarily causation.

“We can see that some deficiencies related to the design controls often will precede a Warning Letter,” Thompson writes. “Frankly, all elements of a quality system are important, but you can imagine that FDA might be particularly disturbed if they do not have confidence that the product was well-designed to meet its intended use.”

Other categories that Thompson says could be interpreted as indicative of a significant failure of the quality system are:

a quality policy;
information adequate to evaluate whether a medical device report is necessary; and
in the context of risk management, an adequate assessment of risk to determine whether a recall might be necessary.

“It’s not hard to see in those cases why FDA might conclude that a Warning Letter is appropriate,” Thompson concludes.

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