Medical Device Accessory or Component and the FDA – The Fine Line Between Them

Medical Device Cybersecurity

Determining if your medical product or innovation should be considered a component or an accessory is a critical early-life cycle inflection point. In fact, the distinction between the two terms has long been the subject of debate and interpretation.

In August 2017, the FDA began a new effort to classify a “list of [medical device] accessories that the Agency believes are suitable for distinct classification into class I.”  However, this effort lead to even more questions and less understanding between the classification designations and the actual device.

Let’s try to break this down to help with the clarification process between an accessory vs component:

  • What does the FDA consider an accessory versus a component?
    • An accessory is intended to support, supplement, and/or augment the performance of one or more devices, often called “parent devices”. It is considered a finished device—meaning it is ready for use or capable of functioning.
    • component (in 21CFR 820.3) is defined as “…any raw material, substance, piece, part, software, firmware, labeling or assembly which is intended to be included as part of the finished, packaged and labeled device.” In other words, it would serve no direct medical purpose by itself, in the form that you deliver, and you are not selling directly to patients/end users/health care providers.
    • 21CFR 807.65(a) explicitly exempts “a manufacturer of raw materials or components to be used in the manufacture or assembly of a device…”  This means the parts or sub-components that go into make a device are exempt from Registration. The creator of the final device bears the burden of Registration.

Let’s talk about some possible scenarios where this designation is important.

Company A makes sensors that are incorporated into a finished blood monitor made by Company T.

  • According to the FDA, Company A’s sensors are components that are exempt from Registration. The sensors, as delivered, cannot be used in their existing form. Nor are they packaged or labeled for consumer or physician use.
  • Company T will file with the FDA for their finished device—using a premarket application (510K submission).

Company M makes a coupler that can fit any endoscope on the market today.

  • This coupler is classified as an accessory by the FDA because it is a fully-functional product that can be added or used in conjunction with another regulated finished good
  • Accessories, unless exempt, may need their own 510K—it’s important to work with experiences regulatory experts to ensure your product is properly classified.

In order to avoid unnecessary regulatory delays, thought must be given to the differences between an accessory and a component. The fine line between the two, if left unidentified, can make a difference in the overall success of the submission.

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