Article preview from "The Gray Sheet" - March 11, 2013
A new draft guidance tries to reassure manufacturers that they can make changes to improve a device's performance or safety without fear that FDA will necessarily require a recall. But early reactions suggest industry may not be happy with at least one component of the document.
Article preview from "The Gray Sheet" - March 11, 2013
FDA hopes a new draft guidance will ease industry jitters and encourage device firms to improve their products without fear that the existing versions will need to be recalled.
The Feb. 22 document reassures manufacturers that just because they change a device to improve its performance or safety "does not necessarily mean" that the existing device needs to be recalled. (See "Regulatory News In Brief" — "The Gray Sheet," Feb. 25, 2013.)
"We heard from industry ... concerns that manufacturers feel anxious about initiating product improvements for fear that the FDA will regard those improvements as recalls and require the manufacturers to process them as such. That is not where we want to be on this issue," said Steven Silverman, director of the CDRH Office of Compliance.
The guidance does two main things: First, it clarifies the difference between a product enhancement and a recall, explaining that a product enhancement is a change to a non-violative device, whereas a recall is a change to remedy a violation, such as failure to meet specifications. Second, the guidance explains the situations in which companies need to file a part 806 "Corrections and Removals" report with FDA.
Device manufacturers requested the guidance, according to Silverman. But the policy serves FDA's interests as well, he noted.
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