The FDA issued new guidance that aims to clarify whether a change in a medical device may require a recall – or is simply an “enhancement.”
According to a notice published last week in the Federal Register, companies may have trouble determining whether an update to their product meets the criteria for a recall. The guidance formally defines an enhancement and presents a Q-and-A as well as sample scenarios to illustrate its recommendations.
“It will make the process of determining whether a modification is an enhancement that much clearer, and companies can proceed with more confidence that they’re doing the right thing,” said Jeffrey Secunda, vice president of technology and regulatory at Advanced Medical Technology Association (AdvaMed), a medical device trade group.
According to FDA, an “enhancement” is a change that improves the quality of the device — something that makes the device better meet the consumer’s needs — but it is not something that remedies a violation of the Federal Food, Drug and Cosmetic Act.
Joe Penkala, who runs a consulting firm that represents several medical device manufacturers called Compass Strategies LLC, said the guidance was needed.
“Up until this point, the FDA had never really defined the term ‘enhancement’ and so manufacturers risked the possibility that their routine upgrades and enhancements aimed at improving performance might be incorrectly viewed as a recall by the FDA,” he said via email.
It’s particularly an issue in software-driven medical devices, like pacemakers or infusion pumps, that are designed to receive software upgrades, Penkala said. Much like phone apps, these devices receive updates to improve their software’s efficiency.
Secunda said that his group was pleased with the guidance. In an earlier draft, the FDA had recommended establishing a reporting requirement for product enhancements that had a safety component, even if it did not require a recall. For example, a company that was increasing the volume on an alarm as a result of customer feedback, and not as a result of a violation, might have to make a report, he said. The new guidance does not make this requirement.
The guidance, though technically nonbinding, shows FDA’s current thinking, Secunda said. “One can expect that the guidance will be used by both premarket reviewers as well as the client looking at devices on the market.”
Secunda added, “This is big stuff. Companies put a lot of effort into getting it right when they think of an enhancement.”
