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By EAS Senior Consultant Paul F. Tilton

Do you know when a product enhancement is considered to be a recall in the eyes of the Food and Drug Administration? If not, I draw your attention to the draft guidance from FDA entitled Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements. Using plain language and a flow chart, the Guidance offers FDA’s perspective on the differences between the two. It was distributed for comment on February 22, 2013. The comment period ended in May, and FDA is now considering the comments received. I recommend that firms consider this guidance and seek consultation if necessary before making any changes in device design, labeling or manufacturing processes.

I speak with some experience. For twelve years I was a chief of the Ob/Gyn, Gastroenterology and Urology Branch, in the Division of Enforcement, Office of Compliance (OC), Center for Devices and Radiological Health (CDRH). Prior to my retirement in early 2012, certain steps taken by my branch in coordination with others in CDRH were instrumental in the genesis of this document. Let me explain. We became aware that a manufacturer had proposed a design change in a marketed device via the Premarket Approval (PMA) supplement process. Concurrently, we noted that several adverse events involving the same device had been reported through the Medical Device Reporting (MDR) system. Was there a connection?

After in-house (i.e., CDRH and the FDA district office) discussion, we opened dialogue with the manufacturer and shared points of view. The firm acknowledged the original design of the device might have been a contributing factor to the injuries reported via the MDR process, but concluded, nevertheless, that the design change was a product enhancement and a recall was not warranted. We expressed the need for a voluntary recall because of the seriousness of the health hazard, the likelihood of recurrence and other aspects.

This was not a unique situation. Quite often we encountered similar situations requiring meetings with manufacturers to clarify expectations. In this case, as always, we worked closely with the recall coordinator in the FDA district office and engaged the manufacturer only after having an FDA Health Risk Assessment in hand and the support of experts from OC, the Office of Device Evaluation (ODE), the Office of Surveillance and Biometrics (OSB) and others.

In the above situation, the Center’s point of view prevailed, and the manufacturer agreed to conduct a voluntary recall. Once that matter was settled, the firm asked to meet with us to get a better understanding of FDA’s processes to avoid similar problems in the future. We welcomed this discussion and recognized the need for a Guidance document.

The Guidance includes: 1) definitions of terms, 2) identification of what a recall is and isn’t, 3) clarification of violative and non-violative devices, 4) a recall decision making flow chart, 5) recall reporting requirements, and 6) product enhancement reporting requirements. It also discusses associated regulations, including 21 CFR 803 (Medical Device Reporting) and 21 CFR 806 (Reports of Corrections and Removals). A Q&A format is used throughout.

The Guidance is still in draft form and may change somewhat to reflect the comments received. But for now it is of value for helping to understand FDA’s perspective on device recalls versus product enhancements.

Posted in Issue of the Month, Medical Devices and tagged .