Thank you for your response. You have provided me with very useful information. I appreciate that. Have a great day.
Original Message:
Sent: 2/7/2024 12:57:00 PM
From: Kevin Randall
Subject: RE: Convenience Kit Components
In the way your scenario is currently worded, no. But with some adjustments, yes. Yet in reality and practicality for this particular case, probably not. I explain further below.
I'm concerned that your supplier may be projecting onto you (whether deliberately or inadvertently) certain profound requirements that you might think are being covered by the supplier, when in actuality they are not. The attributes you've mentioned don't necessarily immediately disqualify this scenario from the Convenience Kit route. But to be sure, considerable provisions and corrections and clarifications need to be made in your strategy. For example,
- FDA product code FMF is for barrel/piston syringes. Thus, I'm not yet seeing how FMF is the correct product code for a filter. If FMF isn't correct, then we need to know the correct product code to be able to fully assess its eligibility. If the filter is simply a piece/part of the source's FMF barrel/piston syringe finished device, then yes, the filter is indeed a "component" from the perspective of the source's syringe intended use and context. Yet the filter is not a "component" from the perspective of anyone who intends to market the filter on its own for a medical intended use apart from a syringe. Instead in that latter scenario, the filter becomes a "finished device" rather than a "component" and thus subject to the applicable finished device requirements. Be sure these variables are properly elucidated for your scenario in order to know the proper premarket regulatory strategy.
- FDA would generally define a filter, even if nonsterile, as a "finished device" rather than a "component" if marketed in the way you've described. This remains true whether it's for FDA's usual QS Regulation definition or for its use in the Convenience Kit context. Thus, be careful, because when folks deliberately distinguish an FDA item as a "component", then they are often doing so in order to avoid the requirements (e.g., see my bullet below) applicable to a "finished device". In other words, the nonsterile filter must meet the finished device sterility (or other) filter requirements before it can legally be made part of the Convenience Kit.
- Ultimately, Convenience Kits must consist of "legally marketed" devices. In basic terms, this means, for example, that they must be in their 510(k)-cleared state. In other words, a nonsterile device in a Convenience Kit may not qualify as being in the device's "legally marketed" form if that device's 510(k)-clearance requires sterility. Thus, to be legally included in a Convenience Kit, such a device sourced in nonsterile form by the Kit assembler/manufacturer must be sterilized before it can be, or as part of being, legally included in the Kit. Here is where great care is needed because such sterilization could be logistically realized in various ways (e.g., by the Kit assembler, by a third party hired by the Kit assembler or the filter manufacturer, or maybe even by the end user) in order to qualify it to be in its "legally marketed" [e.g., sterile 510(k)-cleared] state. Specifically, if such sterilization doesn't happen under watch and authority and instruction of the 510(k)-cleared filter manufacturer including appropriate corresponding provisions made in the filter manufacturer's own quality system and filter design controls, then it causes the Kit assembler/manufacturer to become the party responsible for achieving the "legally marketed" [e.g., 510(k)-cleared, or other] state of that filter. In other words, for example, if the Kit assembler/manufacturer is sterilizing the filter independent of the 510(k)-cleared sterile filter manufacturer's oversight, authority, quality system, design controls, etc., then the Kit assembler needs its own 510(k) (or other legally marketed authorization) to include the filter in the Kit.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 07-Feb-2024 07:55
From: Wanda Dumont
Subject: Convenience Kit Components
My company purchases a non-sterile filter from a supplier. The sterile version of this filter is considered FDA product code FMF. The supplier calls the non-sterile filter a component. If we purchase this filter, non-sterile, and pack it with a convenience kit, does this "component" meet the guidance for a convenience kit?
Thank you for any answers you are able to provide.
Wanda
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Wanda Dumont
Quality & Regulatory Specialist
Dover NH
United States
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