By Pamela Forrest, Elaine Tseng, Quynh Hoang and Lynette Zentgraft
FDA’s statutory authority to regulate medical devices extends to any "accessory" to a medical device.1 Medical device manufacturers often struggle with the question of whether a product is a stand-alone device or an accessory to a device and how this determination affects FDA regulation. FDA recently attempted to provide some clarity on these issues in its draft guidance titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015) ("Draft Accessory Guidance").2
Definition of an accessory
Confusion around the regulatory status of a product may stem, in part, from the fact that FDA regulations do not define the term "accessory." FDA has proposed to define an accessory as "a device that is intended to support, supplement, and/or augment the performance of one or more parent devices" and a parent device as "a finished device whose performance is supported, supplemented, and/or augmented by one or more accessories."3 In the Draft Accessory Guidance FDA 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 For example, rechargeable batteries used with an automated external defibrillator would be considered accessories.
- 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 One example is when a balloon catheter is used to insert a heart valve.
- A device "augments the performance of a parent device by enabling the device to perform its intended use more safely or effectively."6 A guidewire, for example, used with a bone-cutting saw increases the precision of the parent device and therefore would be considered an accessory to the saw.
An important, and often misunderstood concept that FDA also clarifies in the Draft Accessory Guidance is that the determination of whether a product is intended for use with one or more parent devices will be based on the labeling and promotional materials for the product (i.e., the potential accessory), rather than the labeling and promotional materials for the parent device.7 Therefore, companies will need to analyze whether and how their planned marketing strategies will influence a product’s regulatory status.
Companies also often question what regulatory requirements apply to a product that is considered to be a medical device accessory. FDA employs a risk-based system for the classification and regulation of medical devices, with Class I devices being the lowest risk and subject to the least amount of regulation, and Class III devices presenting the highest risk and subject to the greatest amount of regulatory oversight. Historically, FDA’s policy has been that an accessory takes on the classification of the parent device, unless the accessory has its own unique, standalone classification regulation. For example, a balloon catheter used to implant a heart valve (a Class III device) would, because the catheter lacks its own classification regulation, be treated in the same manner as the heart valve, its parent device, i.e., regulated as a Class III device and approved through the premarket approval (PMA) process. This can be burdensome for companies because the accessory would be subject to the same regulatory controls as the parent. If modifications were made to the balloon catheter, for example, a company may need to obtain approval of a PMA supplement for the modifications, even though no changes were made to the parent heart valve device.
Further, the Draft Accessory Guidance states that classification of accessories through issuance of a unique, stand-alone classification regulation "has traditionally been considered for accessory types that may be used with multiple parent devices or that have unique standalone functions."8 An example of an accessory that is used with one or multiple parent devices is a pacemaker magnet, which is regulated as a Class I device, while the parent device, a pacemaker, is a Class III device. This statement suggests that FDA may narrowly interpret when a product falls within a separate classification and thus does not take on the classification of the parent device. This interpretation could have a significant impact on a company. For example, manual orthopedic instruments are classified as Class I devices exempt from 510(k) review. Under the Draft Accessory Guidance, a manual orthopedic instrument that is designed for use with a specific orthopedic implant or line of implants, instead of with multiple orthopedic implants, could arguably be considered by FDA to not fall under the separate Class I regulation but, rather, to take on the classification of the parent implant (e.g., Class II, requiring 510(k) clearance).
Through the Draft Accessory Guidance and other public statements,9 FDA has indicated its belief 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 lower risk accessories to pursue classification through the Automatic Evaluation of Class III Designation (de novo classification) process (for new types of accessories) or to seek reclassification of an accessory through a reclassification petition (for accessories previously classified as part of 510(k) clearance or PMA approval for the parent device or via an applicable standalone classification regulation).
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. All manufacturers, however, should carefully read the Draft Accessory Guidance and consider how FDA’s proposals may impact their business.
1. 21 U.S.C. 321(h). ↩
3. Draft Accessory Guidance at p. 4. ↩
4. Id. at p. 5. ↩
5. Id. ↩
6. Id. at p. 6. ↩
7. Id. at p. 5. ↩
8. Id. at p. 3. ↩
9. February 24, 2015 Webinar “Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories,” http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm. ↩
10. Draft Accessory Guidance at p. 6. ↩
Pamela Furman Forrest and Elaine Tseng are partners in King & Spalding’s FDA & Life Sciences Practice Group. Quynh Hoang is a Senior Regulatory Consultant for the firm. Lynette Zentgraft is a Regulatory Submissions and Strategy Expert for the group.