I Do Not Recall If Medical Device Enhancements Are Better

Friday, March 8, 2013, by Justin Mann

If a manufacturer wants to change the color of its implantable cardioverter-defibrillator, finding that patients like blue more during product demonstrations, what kind of change is this considered?  What needs to be reported to the FDA?  To the public?  What if that same manufacturer finds a supplier with batteries that last twice as long as those used in the device’s original Premarket Approval?  The Center for Devices and Radiological Health (CDRH) at the FDA has taken a crack at answering these questions late last month when it issued a draft guidance document: “Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements” (Docket ID: FDA-2013-D-0114).  The Guidance walks us through the FDA’s thought process for distinguishing between product recalls and product enhancements.  After spending more than half of the document on this distinction, the FDA leaves you feeling unfulfilled by not explaining what you should do with this information.

To begin the analysis, we are only talking about marketed devices, and the “changes” captured by the classification, called “corrections,” are anything you would generally consider a change (“repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device”).  If you are making a change to a marketed device, you need to ask yourself four questions about the device:  1) Is it failing to meet specifications (e.g., battery supposed to last 5 years, but failing after 4 years)?  2) Is it failing to perform as intended (e.g., not engaging in certain situations)?  3) Is its labeling “false, misleading, or otherwise inaccurate” (e.g., labeling says the device is not affected by vigorous exercise, but a software adjustment is necessary for this to always be true)?  4) Is it otherwise in violation of an FDA regulation?  If you answer “yes” to any of the questions, then the change is a recall.  If you answer “no” to all of these questions, then the change is a product enhancement.

The problem with the Guidance is that once you have put in the work of figuring out how to classify your change, it tells you nothing about what that means: “[t]his guidance does not attempt to address all regulatory obligations associated with a change to a marketed device.”  It does describe the reporting requirements for 21 C.F.R. 806, but the analysis is identical for both types of changes! (If the change was to correct a “risk to health,” then report.  If not, then no reporting requirement.)  Having been responsible for FDA reporting compliance in the past, I would prefer to see a table or flow chart that lists the regulatory obligations associated with a product recall versus a product enhancement.  Considering the term “product enhancement” does not appear in FDA’s regulations, at the very least, they should list the regulations that are pertinent to this type of change.  As one commentator reminds us, fully understanding the regulatory requirements of a change are important because even errors in 806 reporting can have criminal and civil implications under misbranding provisions.