Anne, the query pertains to 'components' (as opposed to 'accessories') and it is important to make this distinction, since accessories are considered to be finished devices while components are not (normally) treated as devices.
In regulatory terms, a component is defined under 21 CFR 820.3(c) 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'. Contrast this definition with 21 CFR 820.3(l) where a finished device is defined as 'any device
or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized'.
One fundamental difference is that the finished device cannot achieve its intended use in absence of the component, whereas an accessory may support, supplement and/or augment the performance of a finished device. A component cannot be used 'as is', as it has no medical or clinical purpose in and of itself, and can only function when incorporated into a finished device. As an example, consider the wheels on a mobility scooter. The scooter cannot achieve its intended use (to provide mobility to persons confined to a seated position) without the wheels. On the other hand, a rear-view mirror on the scooter would be an accessory, as it adds further functionality, but the scooter can certainly meets its intended use without the rear-view mirror.
Furthermore, under 21 CFR 820.1(a)(1) component manufacturers are exempt from the requirements of the Quality System Regulation.
Identifying a component as an accessory can lead to complications, not least in the regulatory risk and class of the item, or meeting requirements for medical device reporting under 21 CFR 803 amongst others.
FDA guidance 'Who Must Register, List and Pay the Fee' clarifies that a component that is supplied to an OEM device manufacturer for integration into their finished device are not required to Register, List, or Pay fee :
https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/registrationandlisting/ucm053165.htm
So to answer Mike's original question, as the component is supplied (as a spare part) directly to end-users, my interpretation is that both the finished device and the spare part component should appear on the Device Listing. The manufacturer's ER&DL will then reflect the trade names for both the device and the component. In practice, the only additional requirement would be to list the component, as the finished device would already be registered, listed, and all fees paid.
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Homi Dalal RAC
Regulatory Affairs Leader
Christchurch
New Zealand
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Original Message:
Sent: 11-Jan-2019 11:59
From: Anne LeBlanc
Subject: FDA Listing of "components"
Hi Mike
The FDA 2017 Guidance on Medical Device Accessories contains some examples that may help to determine whether these items should be defined as device accessories or as spare parts.
In cases where it's not perfectly obvious, it may be a good idea to note in your files how you reached the conclusions you did. Then if questions arise you can show that you've been attempting in good faith to comply with the regulations.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 11-Jan-2019 09:56
From: Mike Kilkelly
Subject: FDA Listing of "components"
Hi Jean,
The batteries are custom for the device, I only used the batteries as an example. There other custom components for the device that user may wish to replace if the deteriorate with time or become lost of broken and user may want to replace component rather than purchase a full device.
regards
Mike
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Mike Kilkelly
Quality Manager
Galway
Ireland
Original Message:
Sent: 11-Jan-2019 08:29
From: Jean Bigoney
Subject: FDA Listing of "components"
Without knowing details of the components, it is difficult to give a reliable answer. My first question is whether the supplied batteries are specific to this or other medical device applications, or whether these batteries could be (and are) used in non-medical device applications and happen to have been selected for use in this particular device.
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Jean Bigoney PhD, RAC, CQE
Regulatory Affairs Specialist
Morrisville
United States
Original Message:
Sent: 11-Jan-2019 05:12
From: Mike Kilkelly
Subject: FDA Listing of "components"
I have a question regarding FDA listing of components which are supplied as spare parts for a device.
The FDA's document on "Who Must Register, List and Pay the Fee" states that "Manufacturer of accessories or components that are packaged or labeled for commercial distribution for health-related purposes to an end user" must register, list and pay fees.
What application, if any, does this have for manufacturers of devices who also supply "components" (as in spare parts) for that device.
The example I have in mind is a Medical electrical device that is 510k cleared and listed. The company supplies replacement batteries for the device to users. Does the battery have to be listed separately or is the listing of the device (which includes the batteries) sufficient ?
I would be grateful for any feedback.
Mike
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Mike Kilkelly
Quality Manager
Galway
Ireland
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