When is an accessory a device for which an application needs to be submitted to the FDA, and how is the accessory classified?
The answer to that question can be a bit muddy, and although the FDA released final guidance on device accessories and how to classify them earlier this year, the answers are not so clear cut.
An accessory to a medical device is in itself a medical device and is regulated as such with all the same quality system regulations as the parent device, explained Dan O’Leary, president of Ombu Enterprises during a recent FDAnews webinar.
Two New Definitions
The FDA offers two new definitions to determine whether an accessory is a device: “A parent device is a finished device whose performance is supported, supplemented and/or augmented by one or more accessories.” And, an accessory “is a finished device that’s intended to support, supplement or augment the performance of one or more parent devices” ().
Previously, the FDA didn’t say a lot about accessories, but the issue arose when the unique device identification regulations came into effect, and people began to question how UDIs would affect accessories and whether they would require a UDI.
O’Leary said the company should first conduct an analysis to answer the question: “Does this accessory enable the intended use of the parent device, or does it facilitate the intended use of the parent device?” A device can also supplement or augment the performance if it adds a new function or a new way of using the device without changing the intended use of the parent.
For example, an infusion pump stand supports the intended use of an infusion pump, because it holds liquids or medications firmly at an appropriate height and in a convenient reach. The infusion pump can do its work — its intended use — without the stand, but the stand facilitates the infusion pump’s use. Therefore, it’s an accessory to the infusion pump and is a medical device.
Many people would argue that the risk associated with the stand is not the same as the risk associated with the infusion pump. That’s why this accessory might want to be in a different class than the infusion pump, O’Leary advised.
Once the manufacturer has decided the article is an accessory, then it needs to be classified according to its risk profile.
O’Leary suggests using a decision tree to analyze all the ways in which a medical device could harm the patient or user. That means an analysis of performance and intended use.
To figure that out, the manufacturer needs to look at the labeling and promotional materials of the accessory, not the parent device. This is important because it might be a case in which the parent device is in a higher risk class.
De Novo Pathway
If the accessory is a new type of product and has not been classified before and there is no comparable predicate device on the market, the sponsor should use the de novo classification pathway, O’Leary said.
“It may turn out that the accessory is already classified, but historically, it’s in the wrong classification because the accessory does not have the same risk as its parent device, which means that you could ask FDA to reclassify it,” O’Leary said.
Alternately, if it’s a 510(k) device and a company doesn’t believe that those controls are necessary to make the device safe, it can ask for an exemption.
Read the final guidance here: www.fdanews.com/12-29-16-Accessories.pdf
Access the webinar CD/Transcript here: www.fdanews.com/products/53946.