On January 20, 2015, the Food and Drug Administration ("FDA") released draft guidance on the regulation of accessories to medical devices, titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types” ("Guidance"). The proposed Guidance encourages device manufacturers to use the separate pathway process for new accessories to devices for which no predicate device exists but which have controls ensuring safety and effectiveness. The Guidance clarifies what FDA considers an "accessory" and how FDA's risk-based framework for classification applies to such accessories. In addition, the Guidance describes the use of the de novo classification process to classify accessories of a new type under Section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act ("FD&C Act").
Notably, the Guidance provides a new definition of the term "accessory" and serves as a departure from FDA's current practice of classifying accessories in the same class as their parent devices. Instead of linking a new device accessory’s risk classification to the risk classification of the parent device, manufacturers are encouraged to use the de novoclassification pathway to request risk-based classifications for new accessory types. It is possible, therefore, that the path to marketing a new accessory will become less burdensome for manufacturers.
II. What is an Accessory?
An "accessory" is a device that is intended to support, supplement, and/or augment the performance of one or more parent devices.1 The Guidance clarifies that FDA considers an accessory as an article that meets one of the two following criteria:
- Intended for Use with a Parent Device
Whether an article is intended for use with a parent device will generally be determined by the labeling and promotional materials for the potential accessory device (as opposed to the labeling and materials for the parent device).
- Intended to Support, Supplement, and/or Augment the Performance of a Parent Device
The Guidance includes brief descriptions and examples of when a device is considered to "support, supplement, and/or augment" the performance of a parent device. A device supports the performance of a parent device by enabling or facilitating that device to perform according to its intended use. Next, a device supplements the performance of a parent device if it adds a new function or a new way of using the parent device, without changing the intended use of the parent device. Finally, a device augments the performance of a parent device by enabling the device to perform its intended use more safely or effectively. Augments includes improving the performance of a parent device by enabling it to perform more quickly or improving usability or convenience for the device user.
III. Risks and Regulatory Controls
Under the Guidance, FDA states that it intends to determine the risk of accessories and the controls necessary to provide a reasonable assurance of their safety and effectiveness according to their intended use in the same manner that is used to determine such for devices that are not accessories. In other words, FDA will determine the risks of an accessory itself when used as intended with the parent device, and will evaluate not only the risks imposed by the accessory's impact on the parent device but also any risks of the accessory independent of the parent device.
IV. De Novo Classification Process
A de novo classification process is laid out in Section 513(f)(2) of the FD&C Act, which FDA encourages submitters to use in requesting classifications of new types of accessories. The Guidance outlines thede novo pathway procedures. If the submitter demonstrates that the de novo criteria are met (i.e., accessories for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness), FDA will grant the de novo, which classifies the new accessory (and accessory type) in Class I or Class II. The accessory may then be marketed immediately and serve as a predicate device for future 510(k) premarket notifications. FDA will also publish a notice in the Federal Register announcing the classification and the controls necessary to provide reasonable assurance of safety and effectiveness.
If the de novo is declined, the accessory remains in Class III and may not be marketed.
Overall, the Guidance serves as an acknowledgment by FDA that many devices have accessory components that, when used as intended, may have a lower risk profile than the parent device and therefore may be justifiably subject to lower regulatory requirements. This is encouraging news for many device manufacturers. While the Guidance is still in draft form, the presumption is that various types of medical device accessories supporting, supplementing or augmenting higher risk medical devices may be given a pathway by which to avoid classification based on the risks of such parent device.
The draft Guidance was published in the Federal Register on January 20th, and comments are due by April 20, 2015, before final guidance is issued. This is an opportunity for manufacturers to provide additional feedback to the de novo process.