SILVER SPRING, Md. — The difference between medical device recalls and medical device enhancements is one that has confused lawyers and patients alike.

In the fall of 2014, the FDA issued its finalized guidance clarifying the distinction between medical device recalls and enhancements. This is a critical difference, because depending on which definition an update to a medical device falls under will determine reporting requirements. The new rule also clarified exactly what constitutes a recall.

The draft guidance from 2013 stated “as long as your change is initiated to reduce a risk to health posed by your device, even if your change is not a recall, you must submit an 806 report unless all the information has already been provided to FDA under the Medical Device Reporting requirements (21 C.F.R. Part 803).” The rule was envisioned to play out as such: 1) a manufacturer would disclose they were updating a device; 2) the FDA would review the report; and 3) the FDA would determine if it qualified as a recall.

The drug and device industry was extremely worried about this change because they believed it meant they had to report product enhancements beyond those that led to recalls. To get around these disclosure requirements, the manufacturers became heavily involved in the rule making process and offered feedback to the FDA. Now the rule creates a distinction between device enhancement and recall.

Recalls and Enhancements

Recalls are when a device needs to be corrected and removed. The key difference is whether the changes made to the device are intended to resolve a failure to meet certain specs or failure to perform as represented. This includes changes that are meant to deal with devices that are facing an increase in overall failure rate or single failure rate, or that identify a new situation in which the device might fail. Recalls are attempts to fix a problem in the device that would otherwise result in a violation of federal regulations.

Enhancements, on the other hand, are defined as changes to improve the performance or quality of the device, but these changes are not trying to fix something wrong with the device. Rather they are focused on making it more user friendly, easier to make, or improve non-critical safety or performance issues.

Going forward, this distinction matters to plaintiffs and victims of defective medical devices because this could arguably mean less information will be available to the FDA and consumers. Now, device manufacturers will try and claim changes to their product are being made for enhancement purposes, not to fix a critical or life-threatening issue, in order to avoid disclosing the change to the FDA. This may put consumers at risk and certainly flies in the face of transparency.

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