I think a thin fine line between accessories on the one hand and parts/components on the other hand is almost impossible to decide. The way Richard tries to explain it appeals to me, he makes the difference in 'to operate' to 'perform the intended use'.
A medical device may need a keyboard to operate, the keyboard in itself is not assisting in performing the intended use.
A mobile device and the operating system are needed to operate with a medical device and are parts/components; an specific app is assisting the medical device to achieve the intended use and is an accessory.
From a long time ago I remember a discussion about a infrared lamp for heat treatment and pain relief. The device was nothing more than the somewhat bulky lamp,a lamp socket, a holder and some wiring and a wall plug. The manufacturer argued that the lamp was to be considered as the medical device and the rest were parts/components, whereas the regulator argued that the whole 'system' was a medical device, since that is how the 'system was sold to the users. The issue remained unresolved, unfortunately.
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Peter Reijntjes
Principal Consultant Regulatory & Quality Affairs
Arnhem
Netherlands
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Original Message:
Sent: 09-Mar-2020 11:36
From: Maria Ida Iacono
Subject: accessory vs. parts/components
Thank you both for your kind answer.
How would you consider accessories like mobile devices (smartphones or tablets) or battery chargers? which type of regulatory requirements apply to this type of products?
Thanks again
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Maria Ida Iacono
Paris
France
Original Message:
Sent: 04-Mar-2020 09:07
From: Richard Vincins
Subject: accessory vs. parts/components
Accessories can be required or optional for use with the device. Parts or components are integral parts of the main device. I am not sure there is a clear definition anywhere, even for non-medical products but generally an accessory is something that can be detached used with the device or not. A part or component is something integral to the device meaning the device will not operate without the part or component. The device can still operate and perform with or without the accessory. But even that there is some question whether an accessory is required or not in order to make the device work.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 03-Mar-2020 11:37
From: Anne LeBlanc
Subject: accessory vs. parts/components
Sometimes the line is fine, sometimes more clear.
The FDA guidance is good, but necessarily general.
It's hard to apply it to your products without knowing what kind of thing they are.
Here's a distinction you might try on your product... If it's physically separate from the parent device, it's not a component of it.
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Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 03-Mar-2020 05:38
From: Anonymous Member
Subject: accessory vs. parts/components
This message was posted by a user wishing to remain anonymous
Hi all,
although I read several definitions, posts, and the FDA guidance regarding accessories, I still struggle with the fine line between accessory vs. parts.
Can somebody provide some practical guidance regarding the difference between the two? Initially I thought that if something is "optional", then it is an accessory, otherwise it is a component. However, in the guidance there is the following sentence that dismantles my theory:
"Thus, if the device is intended to support, supplement, and/or augment the performance of one or more parent devices, we intend to consider the device to be an accessory whether it is required or optional."
Also, what about mobile tablets or smartphones etc. completely dedicated to the parent device? Are these considered accessories?
Thanks in advance