On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015) (“Draft Accessory Guidance”).1 The Draft Accessory Guidance provides FDA’s proposed definition of an accessory and explains the agency’s process and proposal for classifying medical device accessories. Comments on the draft guidance may be submitted to www.regulations.gov until April 20, 2015 and should reference docket number FDA-2015-D-0025-0001.
What is an Accessory?
In the draft guidance, FDA defines an accessory as “a device that is intended to support, supplement, and/or augment the performance of one or more parent devices.”2 A parent device is defined as “a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.”3 FDA further explains that determination of whether a product is intended for use with one or more parent devices will be based on the labeling and promotional materials of the product (i.e., the potential accessory) rather than the labeling and promotional materials of the parent device.
The Draft Accessory Guidance also explains when a device is intended to support, supplement or augment a parent device. A device “supports the performance of a parent device by enabling or facilitating the device to perform according to its intended uses”4 (e.g., a rechargeable battery used with an automated external defibrillator).” A device “supplements the performance of a parent device if it adds a new function or new way of using the parent device without changing the intended use of the parent device”5 (e.g., a balloon catheter used to insert a heart valve). Finally, a device “augments the performance of a parent device by enabling the device to perform its intended use more safely or effectively”6 (e.g. guidewire used with a bone-cutting saw increases the precision of the parent device).
Classification of Accessories
The draft guidance explains the current process by which accessories are classified:
- Through the 510(k) process. In these cases, the classification regulation only identifies the parent device; however, through the 510(k) submission, FDA finds accessories to the parent to be substantially equivalent. As such, the accessories take on the same regulation as the parent device.
- Through the PMA process. Accessories to PMA approved devices “may also be approved in the PMA, in which case they would remain in class III along with the parent device.”7
- Express inclusion of accessories in the classification regulation or order for the parent. Under these circumstances, the classification regulation specifically cites both the parent device and corresponding accessories. Under these circumstances, the accessories are typically placed in the same class as the parent device; however, FDA has on occasion placed the accessories in a different class (see, for example, 21 C.F.R § 876.5540, “Blood access device and accessories”).
- Issuance of a unique, separate classification regulation or order8 for the accessory. In these cases, a classification regulation, separate from that of the parent device, has been established. Classification of accessories in this manner “has traditionally been considered for accessory types that may be used with multiple parent devices or that have unique standalone functions.”9
In the Draft Accessory Guidance, FDA states it believes that the regulation of accessories should be risk-based and acknowledges that “the risk profile of an accessory can differ significantly from that of the parent device, warranting differences in regulatory classification.”10 FDA encourages manufacturers of new types11 of accessories to pursue classification through the Automatic Evaluation of Class III Designation (de novo classification) process. The draft guidance provides additional information on the type of information that should be submitted to support a de novo petition for an accessory device.
The concepts outlined in the Draft Accessory Guidance may be most useful for companies planning to seek PMA approval for a device with which lower risk accessories may be used. It is worthwhile to consider whether seeking separate classification of those accessories, through the de novo process, would be beneficial for regulatory and/or business reasons, rather than simply treating the accessories as Class III devices.