The Food and Drug Administration released new guidance on December 30, 2016 regarding the regulation of accessories to medical devices. An example of an accessory to a medical device would be a guide wire, which helps cutting of the bone. The definition of “device” is set forth by the Food Drug & Cosmetics Act (FD&C Act), which includes any accessory. Thus, all accessories to devices are also regulated under the FD&C Act.
Traditionally, accessories have been classified in the same category as their parent device unless the FDA determined that the accessory should have a separate and unique classification. Now, the guidance
references the 21st Century Cures Act
, which explains that accessories should only be classified based on their intended uses, not necessarily in whichever category the corresponding device falls in. The guidance also states that if an accessory has a different risk profile than the parent device, then it should be classified accordingly rather than being classified the same as the parent device. Ensuring that accessories with different risks than their parent devices are classified separately will ensure that they are not over or under regulated, which will also ensure the safety and efficacy of the product.
Next, the guidance
provides clarity on the differences between accessories and software by specifying which software products meet the definition of an accessory and which are “software as medical devices” (SaMD). The guidance defines
an accessory as “a finished device that is intended to support, supplement, and/or augment the performance of more or more parent devices.” Alternatively, SaMD is defined
as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” For example, a stand-alone software program that analyzes data generated by a device, such as a heart rate monitor, is considered a SaMD, because it functions on its own and is not intended to supplement the performance of another device. When a SaMD is used with a device, it may be considered an accessory if it is deemed to supplement or augment the performance of the device it is coupled with.
Lastly, the new guidance
explains how to classify an accessory. To determine this, the FDA asks two questions
: First, whether the article is an accessory, and second, what is the risk of the accessory when used as intended with the parent device, and what regulatory controls are necessary to ensure safety? To determine whether an article is an accessory, the FDA will analyze whether the item is intended for use with a parent device. This is determined
by looking at the labeling of the item and concluding whether it is meant to support, supplement, or augment a parent device. If yes, then the item is an accessory. When it is determined that the item is an accessory, it will be classified through the De Novo process
, which permits manufactures to request risk and regulatory clarification on types of accessories that do not yet exist, and that are at low to moderate risk. The manufacturer can submit a De Novo request to the FDA with a description of the accessory and the recommended classification. The accessory can be marketed as soon as the request is approved.
Cassey Shashaty is pursuing her law degree and health law certificate at DePaul University College of Law in Chicago. Cassey completed her undergraduate degree at Florida State University in political science and international affairs. Cassey is interested in how health care legislation affects individuals and their rights as patients.