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Medical Device Update: Distinguishing Medical Device Recalls from Medical Device Enhancements

On October 15, the U.S. Food and Drug Administration (FDA) issued the final guidance “Distinguishing Medical Device Recalls from Medical Device Enhancements.” This guidance revises and finalizes the draft version that generated significant controversy when it issued on February 22, 2013. The final guidance clarifies when a change to a device constitutes a medical device recall, distinguishes device recalls from device enhancements, and clarifies reporting requirements under 21 C.F.R. Part 806.

Controversy Regarding Part 806 Reporting Requirements for Device Enhancements

The most notable revision of the final guidance addresses a controversial recommendation in the draft guidance on Part 806 reporting requirements for recalls and device enhancements. When the draft guidance was issued in early 2013, it triggered significant industry comments and concerns because it stated that a “product enhancement” may be reportable under FDA’s correction and removal reporting requirements at 21 C.F.R. Part 806.[1] This statement was made even though the draft guidance described a product enhancement as “a change to improve the performance or quality of a . . . non-violative device” and FDA’s Part 806 reporting regulations require reports only if a correction or removal was initiated to “reduce a risk to health” or “to remedy a violation of the act caused by the device which may present a risk to health.”[2] In response to industry members’ concerns, the final guidance deletes the section on product enhancement reporting requirements and states instead that “[m]edical device enhancements do not require the submission of an 806 report.”

Final Guidance Clarifies Difference Between Recalls and Device Enhancements

The primary purpose of the final guidance is to distinguish recalls from device enhancements. The guidance states that a recall can be any correction or removal of a device that has been distributed when the device is in violation of the Federal Food, Drug, and Cosmetic Act and/or FDA regulations and the violation is one against which the FDA would initiate legal action. By contrast, a product enhancement is a “change or improvement to a non-violative device as part of continuous device improvement activities.” To illustrate the difference between a recall and a device enhancement, the final guidance includes several examples that follow the definition of each term. Examples are provided for various types of devices, including in vitro diagnostic (IVD) devices. For example, the FDA clarifies that a modification to improve the sensitivity of an IVD from 95% to 98% when there is no known violation is a device enhancement, but that a modification to “improve” the sensitivity of an IVD device that does not meet the sensitivity it is represented to have (e.g., 95%) is a recall.

Regarding the reporting of recalls to the FDA, the final guidance states that a recall must be reported under Part 806 if the violation that triggered the recall “may present a risk to health” and has not already been reported to the FDA under 21 C.F.R. Part 803 or 1004. Although the draft guidance included factors to consider in determining when a recall may present a “risk to health,” the FDA’s more streamlined final guidance does not include this discussion. The final guidance also deletes the draft guidance section on factors that FDA considers in assessing the degree of health hazard and the recall decision-making chart.


[1]. The final guidance uses the term “device enhancement” instead of “product enhancement.”

[2]. 21 C.F.R. § 806.10.

Copyright © 2022 by Morgan, Lewis & Bockius LLP. All Rights Reserved.National Law Review, Volume IV, Number 303
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About this Author

Elizabeth Bierman, Regulatory and compliance lawyer, Morgan Lewis
Senior Counsel

M. Elizabeth Bierman represents US and international companies in US Food and Drug Administration (FDA) and state regulatory matters that impact the development, manufacturing, and marketing of their products. Beth has more 25 years of experience representing companies that produce a range of products regulated by the FDA, including medical devices, digital health products and mobile medical applications, tissue products, combination products, pharmaceuticals, medical foods, and infant formulas. She also provides guidance on related jurisdictional issues and regulatory...

202-739-5206
Phoebe Mounts, Food and drug attorney, Morgan Lewis
Partner

Phoebe Mounts counsels companies developing drugs, biologics, medical devices, and human cell and tissue-based products on US Food and Drug Administration (FDA) regulations. Her scientific background enables her to assist clients with product approvals for emerging technologies, such as combination products and companion diagnostics, including counseling on regulatory pathway issues and developing preclinical and clinical studies. Phoebe prepares submissions to the FDA, including applications for orphan-drug designation, humanitarian device exemptions (HDEs),...

202-739-5898
Michele L. Buenafe, Morgan Lewis, Regulatory and Compliance Attorney
Partner

Michele L. Buenafe advises clients on regulatory, compliance, and enforcement issues related to the development, manufacturing, marketing, labeling, and advertising of medical devices, human tissue products, pharmaceuticals, controlled substances, listed chemicals, and combination products. She also advises clients on emerging legal issues relating to digital health platforms such as mobile medical apps, clinical decision support software, telemedicine systems, wearable devices, and other health information technology. Michele also serves as a co-leader for the firm’s...

202-739-6326
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