On 15 October 2014, the Food and Drug Administration (FDA) issued its final guidance clarifying the difference between medical device recalls and device enhancements.1 This document replaces the draft guidance issued by the agency in February 2013. Its purpose is to clarify when a change to a device constitutes a medical device recall, distinguish such situations from device enhancements, and clarify reporting requirements under 21 C.F.R. Part 806. Importantly, in the final guidance, FDA no longer expects companies to submit a report under Part 806 for device enhancements to improve a device’s performance or quality that is not meant to resolve a violation of the Federal Food, Drug, and Cosmetic Act (FDCA) or FDA regulations.
Device manufacturers and importers are required to submit a correction and removal report (21 C.F.R. Part 806 report) for actions intended to reduce a health risk posed by a device or to remedy a violation of the FDCA that may present a risk to health. In the 2013 draft guidance, FDA stated that “as long as your change is initiated to reduce a risk to health posed by your device, even if your change is not a recall, you must submit an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).”2 This statement sparked great concern in the industry because it suggested that companies were required to submit reports under Part 806 for product enhancements even if the change did not constitute a reportable correction or removal. The idea was that, upon submission, FDA would review the enhancement and determine whether or not the agency agreed with the company’s determination that the enhancement was not a recall. The final guidance, reflecting industry feedback that such a requirement would create a disincentive to make product improvements in the absence of a known issue, removes this requirement. In contrast to the draft guidance, the final guidance clearly states that changes meeting the definition of a device enhancement do not require submission of a corrections and removal report under 21 C.F.R. Part 806.
Under 21 C.F.R. 7.3(g), a medical device recall is a firm’s removal or correction of a marketed device that is in violation of the FDCA or implementing regulations and against which the agency would take legal action. The final guidance provides several examples of changes that would rise to the level of a device recall. Recalls may be comprised of device corrections or removals. A key distinction between a recall and a product enhancement is whether changes are made to a violative product, with FDA clearly stating that “changes intended to resolve a failure to meet specifications or failure of the device to perform as represented would generally constitute recalls.”3 FDA further elaborated that “an increase in overall failure rate, increase in a single failure mode rate, or the identification of a new failure mode may suggest a failure of the device to perform as represented.”4
By contrast, the Center for Devices and Radiological Health recognizes that continuous improvement activities – designed to enhance the quality, performance, and safety of medical devices – do not always constitute a recall. The final guidance provides a definition of a “device enhancement,” which is a term not defined in the FDCA or FDA regulations. The guidance defines a device enhancement as a change to improve a device’s performance or quality that is not meant to resolve a violation of the FDCA or FDA regulations. Enhancements may also be changes designed to better meet the user’s needs, to make the device easier to manufacture, or to improve a non-violative device’s safety or performance. For example, improving the sensitivity of a diagnostic test beyond that specified in its labeling would be considered an enhancement, as it is an improvement to the device’s effectiveness unrelated to any violation.5
Each situation is fact-specific, and FDA could ultimately disagree with a company’s determination that the change to product in the field was a device enhancement that did not require reporting. The key factor is whether or not the product in the field is violative and reflects the type of issue for which the FDA would take legal action. The guidance, however, is silent as to how companies are to make this assessment, which is subject to interpretation. If a company decides that a change constitutes a device enhancement rather than a recall, and does not submit a corresponding corrections and removal report under Part 806, it should contemporaneously document in its files why the product is non-violative and why the change improves the performance of the device and does not address a quality problem. Companies should be careful to look at quality data sources such as complaints, reports of nonconforming products, Medical Device Reports, Corrective and Preventive Actions, service and repair reports, and trend analyses (including overall and individual failure rates and failure modes), as well as labeling claims, before taking the position that the change is a mere device enhancement rather than a recall necessitating report under 21 C.F.R. Part 806.
Although not addressed by the final guidance, one of the issues that often presents challenges is the implementation of changes to production units on a going forward basis and/or units in inventory, without correcting or removing product in the field. These types of situations should be reviewed in accordance with the company’s health hazard evaluation/recall escalation procedures to assess whether there is a defensible justification for making changes only to product on a going-forward basis and/or still in the company’s control, without changing product in the field.
Companies, of course, should continue to review changes for FDA clearance or approval requirements before implementing them, and changes must be appropriately handled through the firm’s quality system processes and procedures. Further, in the event that companies determine that a 510(k) clearance or premarket approval supplement is needed, the FDA has implemented expedited mechanisms for addressing changes that are necessary to resolve an issue in the field.6