Remember that accessories are considered by FDA to be finished devices. FDA regulates accessories as finished devices.
Note also that when there are multiple devices encompassed by a single 510(k), then FDA calls that bundling, and FDA most definitely includes accessories in that equation.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 05-Oct-2022 04:25
From: Richard Vincins
Subject: Bundling devices in a 510K
Hello Anon,
There is not sufficient information to answer your question; you should seek some expert advice on this approach. There are multiple ways this can be done and if the other products are accessories, this also can be done different ways. In your reference to "bundling" this is more about finished medical devices and not really accessories. Accessories are handled a bit differently in regulatory submissions, so you may want to seek advice in your specific situation as this can be managed different ways and there is not enough information.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 04-Oct-2022 15:27
From: Kevin Randall
Subject: Bundling devices in a 510K
Maybe, maybe not. See FDA's guidance at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bundling-multiple-devices-or-multiple-indications-single-submission.
More details would be needed about the particular types of devices and indications involved in order to definitively decide.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 04-Oct-2022 09:07
From: Anonymous Member
Subject: Bundling devices in a 510K
This message was posted by a user wishing to remain anonymous
Hello,
I'm looking to submit a 510(k) with an option of an accessory which is a device in it own right however doesn't have a FDA product code for the indications we want. The accessory is a common device and I believe currently used for the purpose we intend but on review of the available PC definitions it doesn't fit our indications.
So my question is, would bundling the two device in one 510(k), using the bundling devices guidance fit in this situation and be the best approach for me?
Any experience and guidance would be appreciated
Thanks