FDA Releases Draft Guidance On Medical Device Accessories
By Chuck Seegert, Ph.D.
The FDA has recently released draft guidance related to medical device accessories, which includes how those products are defined. Classification of these devices uses a risk-based framework, and the guidance describes the process for identifying where an accessory fits within that framework. The document was only released to elicit comments from industry and other parties, and is not final or in effect at this time.
Medical device classifications are designed to reflect the levels of risk that a device may cause during its intended use. In some cases, these devices have accessory components that, when used as intended, may have a lower risk profile than the parent device. For example, a Class III parent device may have an accessory with risks that could be mitigated by general or special controls, which would allow the accessory to be regulated as a Class I or Class II device.
In the past some confusion has existed about whether an accessory should be regulated at the same level as its parent device. The traditional pathway has made the approval of new low-risk accessories challenging. In the absence of a predicate device, classifying a new accessory as Class I or Class II has not been straightforward.
Recently, the FDA released draft guidance titled “Medical Device Accessories:
Defining Accessories and Classification Pathway for New Accessory Types.” This new guidance is intended to clarify the confusion surrounding the definition and classification of medical device accessories. Accessories fall under the purview of the FDA because the definition of a device in section 201(h) of the Food, Drug, and Cosmetic Act (FD&C Act) includes its accessories.
Historically, accessories have been classified in two different ways:
- The accessory can be included in the same classification as the parent device, which is regulated through the 510(k) process, the pre-market approval process, and by express inclusion in the regulation or order of the parent device.
- The accessory could receive a unique, separate classification regulation or order. When this classification is used, the accessory is separate from the parent device. It is generally used for accessories with multiple parent devices, or when the accessory has standalone functions.
The new guidance is designed to encourage manufacturers to use the risk-based classification process for new types of accessories. According to the guidance document, the following definitions apply:
- Accessory: A device that is intended to support, supplement, and/or augment the performance of one or more parent devices.
- Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.
The guidance document then lays out the accessory classification approach in light of these definitions, which is summarized below:
Accessory Classification Policy
- Is the article an accessory? To determine this, two questions may be asked:
- Is the article intended to be used with one or more parent devices?
- Is the article intended to support, supplement, and/or augment the performance of one or more parent devices?
- What are the risks of the accessory when used as intended with the parent device(s), and what regulatory controls are necessary to provide a reasonable assurance of its safety and effectiveness?
- Finally, the FDA encourages medical device manufacturers and other parties to take advantage of the de novo classification process of the FD&C Act. This will enable a risk-based assessment of the new accessory, which could provide a pathway to Class I or Class II classification.