Regulatory Open Forum

Hello all,

I had a colleague to ask me this question. I don't have much experience with convenience kits so I told her that I would post here to get your insight. They are looking to market a convenience kit that contains two previously cleared products and one product that will require 510k clearance. Should they mention the two previously cleared products and reference their cleared 510k numbers in the 510k of the product requiring clearance? Or should they just seek clearance of the product separately and add the other products to the kit after 510k clearance? Are there any benefits/risks to either approach? She did indicate that her company is looking to market their product separately, in addition, to the convenience kit.  I thought it was an interesting question so thanks in advance for your feedback.

Hello all,

I had a colleague to ask me this question. I don't have much experience with convenience kits so I told her that I would post here to get your insight. They are looking to market a convenience kit that contains two previously cleared products and one product that will require 510k clearance. Should they mention the two previously cleared products and reference their cleared 510k numbers in the 510k of the product requiring clearance? Or should they just seek clearance of the product separately and add the other products to the kit after 510k clearance? Are there any benefits/risks to either approach? She did indicate that her company is looking to market their product separately, in addition, to the convenience kit.  I thought it was an interesting question so thanks in advance for your feedback.

Hello Charnelle,

It would help to have more detailed information to answer her questions but this is what can be said with the available description. I assume that the product requiring 510(k) approval is a device and not a drug or a biological and that the ultimate goal it to get the products approved as a kit.

According to the FDA Convenience Kits Regulatory Guidance, the product (the new component) that you’ve described could be exempt of premarket notification when:

a) the product’s Intended Use matches with the list of generic types of kits.

This list consists of components that have been cleared through 510(k). Here is the link.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm

b) the manufacturer concludes that any further processing of the kit will not affect significantly the safety or effectiveness of its components.

This is the guidance addressing this topic --"Deciding When to Submit a 510(k) for a Change to an Existing Device"-- here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm

Hello all,

I had a colleague to ask me this question. I don't have much experience with convenience kits so I told her that I would post here to get your insight. They are looking to market a convenience kit that contains two previously cleared products and one product that will require 510k clearance. Should they mention the two previously cleared products and reference their cleared 510k numbers in the 510k of the product requiring clearance? Or should they just seek clearance of the product separately and add the other products to the kit after 510k clearance? Are there any benefits/risks to either approach? She did indicate that her company is looking to market their product separately, in addition, to the convenience kit.  I thought it was an interesting question so thanks in advance for your feedback.

Hello,

Thank you both for your feedback. I am familiar with both guidances. I was able to get more information from my colleague and she indicated that the kit will not fall under any of the convenience kits listed in the Convenience Kit Guidance. The kit will contain 3 medical devices (two cleared (manufactured/marketed by another company) and one device in which they are looking to gain clearance. The question was are there any advantages or disadvantages of mentioning entire kit (all 3 devices) in the 510k? Or is it best to just seek clearance of her company's one device and prepare the kit (with the 3 devices) after clearance? The question came from a regulatory strategy/lifecycle management perspective. For example, the company eventually seeking to gain 510k clearance, manufacture/market the two other cleared devices (currently marketed by another company) on their own? Would this scenario provide an advantage for subsequent 510ks?

Hello Charnelle,

It would help to have more detailed information to answer her questions but this is what can be said with the available description. I assume that the product requiring 510(k) approval is a device and not a drug or a biological and that the ultimate goal it to get the products approved as a kit.

According to the FDA Convenience Kits Regulatory Guidance, the product (the new component) that you’ve described could be exempt of premarket notification when:

a) the product’s Intended Use matches with the list of generic types of kits.

This list consists of components that have been cleared through 510(k). Here is the link.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm

b) the manufacturer concludes that any further processing of the kit will not affect significantly the safety or effectiveness of its components.

This is the guidance addressing this topic --"Deciding When to Submit a 510(k) for a Change to an Existing Device"-- here:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080235.htm

Hello all,

I had a colleague to ask me this question. I don't have much experience with convenience kits so I told her that I would post here to get your insight. They are looking to market a convenience kit that contains two previously cleared products and one product that will require 510k clearance. Should they mention the two previously cleared products and reference their cleared 510k numbers in the 510k of the product requiring clearance? Or should they just seek clearance of the product separately and add the other products to the kit after 510k clearance? Are there any benefits/risks to either approach? She did indicate that her company is looking to market their product separately, in addition, to the convenience kit.  I thought it was an interesting question so thanks in advance for your feedback.