As part of its end of year rush to issue guidance documents, FDA issued a final guidance document, Medical Device Accessories: Describing Accessories and Classification Pathway for New Accessory Types, on December 30, 2016. The title page of a guidance document rarely has anything to comment on, but in this case it is at least worth noting that FDA changed the title from “Defining Accessories” to “Describing Accessories.” Given that there is little more description in the final than there was in the draft guidance, on which we posted here, the purpose of this change is not clear.
The final guidance references the recently enacted Cures Act, which modified section 513(b) of the Federal Food, Drug & Cosmetic Act to require FDA to classify an accessory “based on the intended use of the accessory, notwithstanding the classification of any other device with which such accessory is intended to be used.” This statutory provision is consistent with the position FDA took in the draft and final guidances, in which FDA stated that if an accessory has a different risk profile than the parent, then it should be classified differently.
The final guidance, unlike the draft, includes a brief discussion of software products that meet the definition of an accessory, including those that meet the definition of “Software as a Medical Device (SaMD).” Although not specifically mentioned in the draft guidance, it was assumed that software meeting the definition of a medical device would have been included in the scope of the guidance. The final guidance clarifies that SaMD that meets the definition of a device and uses data from a medical device “does not automatically become an accessory for purposes of this guidance.” The example provided is a stand-alone software program that is intended to analyze radiological images or analyzes specific data parameters generated by a device. The guidance states that the software would be considered a SaMD “but would not be considered to support, supplement, and/or augment the performance of the device that generated the data, and therefore, would not be an accessory.” Although analyzing data from a device would not result in the software being deemed an accessory, the guidance states that software that may be used in combination with other devices may be considered an accessory. This apparent differentiation between the two different uses of the software is not entirely clear, nor is it clear why in one role the software would be deemed an accessory and in the other it would not—or what difference it would make from a regulatory classification perspective whether the software was deemed an accessory or an independent medical device.
The final guidance also includes a few more definitions than did the draft guidance. The draft defined only an accessory and a parent device, whereas the final also includes definitions for component and finished device. Additionally, the definition of an accessory has been modified to be defined as a “finished device” rather than just a “device,” though the extent to which the addition of “finished” may be helpful in distinguishing between a component and an accessory is not evident. It has long been accepted that an accessory is a finished device, subject to applicable regulatory requirements, whereas components are excluded from such regulation. Therefore, adding the word “finished” to the definition of “accessory” does not significantly alter industry’s historical understanding of an accessory versus a component, nor does it necessarily help distinguish between the two.
The examples of accessories provided in the guidance are largely unchanged from the draft, with one notable exception. The draft guidance included as an example of an accessory a rechargeable AED battery, which, as we noted in our prior blog post, seemed to push the limits as to what could reasonably be considered an accessory. The battery example is now absent from the final guidance, and the final guidance states: “non-device-specific off-the-shelf replacement parts (e.g., batteries, USB cables, computer mouse, etc.) may be used with a medical device, but FDA does not intend to consider these products to be accessories or medical devices.”
The focus on use of the de novo classification process remains, although the final guidance fails to provide any additional information regarding the suitability of that process for the vast majority of device accessories. As noted in the blog post regarding the draft guidance, the final guidance is not likely to alter the way in which most device accessories will come to market.