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Class III Device Recalls An Afterthought? Not So Fast . . .

This article was originally published in The Silver Sheet

Executive Summary

Low-risk class III medical device recalls sometimes fade into the background because they comprise only a sliver of the overall corrections and removals in a given year. Nevertheless, manufacturers should be aware that any decisions they make regarding class III actions are still going to receive FDA attention. One example: “The justification for not reporting a recall is an area that the agency frequently takes a very close look at,” CDRH Recall Branch Chief Ron Brown says. When FDA wrote its recalls regulation it left the decision about whether to report class III events up to manufacturers. Reporting such low-risk recalls is not required by the agency, but is obviously encouraged if firms discover that the risk to device users is somewhat significant. Such a gray area can leave firms wondering about when it’s necessary to report class III’s – or even whether they should be reported in the first place.

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