Anjali,
Yes, that is a possibility in answer to your questions, but I would make it very clear in your technical documentation what you are doing, how they are listed, how they are classified, and how they are sold. It comes down to understanding how these accessories can "live on their own" under their own classification, but also being used with the parent device. It should not matter whether keeping an accessory with a parent device or want to use with another device. Because this is in fact why some have to classify their accessories separately as these accessories may be used with other device manufacturer or multiple device manufacturers. In simple terms maybe are my interpretation, but believe me the world of accessories is complex from a classification, risk, use, distributing, and UDI perspective.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 13-Feb-2019 15:23
From: Anjali Nair
Subject: Accessory Classification
Thank you @Richard Vincins. I really appreciate it.
Also, the main motive behind having a separate classification for accessories is, like you said, that we would lie to sell these accessories with other devices that we come up with in the near future.
Would it suffice to let the accessories 'stay' with the current parent device BUT list them separately with a lower risk classification under our Device Listing? In this case we would still be able to use the accessories with any number of devices right?
Also, a basic query that I had - Does 'keeping' an accessory with a certain parent device pose any issues at all when I want to use it with another device?
Thank you
Regards,
Anjali Nair
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Anjali Nair
Los Angeles, CA
Original Message:
Sent: 13-Feb-2019 01:30
From: Richard Vincins
Subject: Accessory Classification
Typically you would make the accessory determination internally with the documented justification why your product is an accessory. If you can justify showing the product is an accessory (according to the definition) with sound rationale, there is probably no need to request a formal determination from FDA. Accessories can be different classification from their parent device, so in your design documentation clearly describe the "system" and how all the accessories are used with the main device. Often times accessories need their own classification as they are being sold separately from the parent device, but generally if an accessory is only used with your device and only for the indications for use, then it can "stay together" with the parent device. Often times companies develop an accessory type of medical device that can be used with many different manufacturers or even different medical device types - these circumstances is where a classification request might be appropriate.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 12-Feb-2019 18:17
From: Anjali Nair
Subject: Accessory Classification
Let me make my question more clear:
My company has a Software as a Medical Device. It has 2 accessories which are also softwares and medical devices in themselves.
If I determine to keep the risk class for the parent device and the accessory the same, do I still have to submit an Accessory Classification Request? Or would the accessory, under express inclusion, be included in the same risk class as my parent device (and in this case I don't have to make any separate applications for the device)?
If I determine that the accessory has a lower risk profile, do I have to submit a separate Accessory Classification Request? Must this request be granted before I file the 510k for the parent device?
Thanks
Regards,
Anjali Nair
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Anjali Nair
Los Angeles, CA
Original Message:
Sent: 12-Feb-2019 17:44
From: Anjali Nair
Subject: Accessory Classification
Hello everybody
My Company's device is a Software as a Medical Device. We have a parent device (software) and a couple of accessories to be used in the future with other parent devices(softwares) that we would develop.
Our accessories have a lower risk profile as our parent device. Would I have to submit the Accessory Classification Request for this purpose?
Here is a link to the guidance where I came across this for the very first time: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm429672.pdf
Thanks
Regards,
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Anjali Nair
Los Angeles, CA
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