Regulatory Open Forum

I wanted to reach out to see if anyone could tell me the regulation to list an Infusion Starter Kit, and a Fresh Whole Blood transfusion set with Donor Set and Recipient Set.  Can the product be re-pack as a convenience kit and the Donor and Recipient Set  can be  also sell as an individual set. I wanted to check on the regulations to do so. Thanks for the guidance!

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Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
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Based on the information you've provided, it appears that these devices would be regulated in the U.S. per 21 CFR 880.5440 as, but not necessarily limited to, product code(s) FPA, BRZ, and/or POQ. Additional details are needed to provide a conclusive regulatory assessment. But here is some general explanation that may facilitate related decision-making:

In general, when sold individually, the aforementioned product types require section 510(k) notification.  If already 510(k)-cleared individually, then they may be kitted together without additional 510(k)-clearance by applying the FDA's convenience kit guidance document (including careful attention to the limitations therein).  For example, if any kit constituent lacks its individual 510(k) clearance, then it must either first be 510(k)-cleared individually, or the kit must be 510(k)-cleared before such a constituent can be included.

Manufacturing of the individual constituents, as well as the kitting operations are both subject to the requirements of establishment registration and device listing in 21 CFR 807.  Also required are the GMP controls from 21 CFR 820.

Hope this helps,

I wanted to reach out to see if anyone could tell me the regulation to list an Infusion Starter Kit, and a Fresh Whole Blood transfusion set with Donor Set and Recipient Set.  Can the product be re-pack as a convenience kit and the Donor and Recipient Set  can be  also sell as an individual set. I wanted to check on the regulations to do so. Thanks for the guidance!

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

Kevin, thank you so much for so a value feedback.

Is any regulation for military and law enforcement multi-mission bag and/or Individual First Aid Kit stock with  medical devices product and other accessories that are not medical devices? What about for restocking them or customer custom bags? Those bags contain class I and Class II devices but do I need to treat the bags as a medical device or as a first aid kit?

Based on the information you've provided, it appears that these devices would be regulated in the U.S. per 21 CFR 880.5440 as, but not necessarily limited to, product code(s) FPA, BRZ, and/or POQ. Additional details are needed to provide a conclusive regulatory assessment. But here is some general explanation that may facilitate related decision-making:

In general, when sold individually, the aforementioned product types require section 510(k) notification.  If already 510(k)-cleared individually, then they may be kitted together without additional 510(k)-clearance by applying the FDA's convenience kit guidance document (including careful attention to the limitations therein).  For example, if any kit constituent lacks its individual 510(k) clearance, then it must either first be 510(k)-cleared individually, or the kit must be 510(k)-cleared before such a constituent can be included.

Manufacturing of the individual constituents, as well as the kitting operations are both subject to the requirements of establishment registration and device listing in 21 CFR 807.  Also required are the GMP controls from 21 CFR 820.

Hope this helps,

I wanted to reach out to see if anyone could tell me the regulation to list an Infusion Starter Kit, and a Fresh Whole Blood transfusion set with Donor Set and Recipient Set.  Can the product be re-pack as a convenience kit and the Donor and Recipient Set  can be  also sell as an individual set. I wanted to check on the regulations to do so. Thanks for the guidance!

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

Kevin, thank you so much for so a value feedback.

Is any regulation for military and law enforcement multi-mission bag and/or Individual First Aid Kit stock with  medical devices product and other accessories that are not medical devices? What about for restocking them or customer custom bags? Those bags contain class I and Class II devices but do I need to treat the bags as a medical device or as a first aid kit?

Based on the information you've provided, it appears that these devices would be regulated in the U.S. per 21 CFR 880.5440 as, but not necessarily limited to, product code(s) FPA, BRZ, and/or POQ. Additional details are needed to provide a conclusive regulatory assessment. But here is some general explanation that may facilitate related decision-making:

In general, when sold individually, the aforementioned product types require section 510(k) notification.  If already 510(k)-cleared individually, then they may be kitted together without additional 510(k)-clearance by applying the FDA's convenience kit guidance document (including careful attention to the limitations therein).  For example, if any kit constituent lacks its individual 510(k) clearance, then it must either first be 510(k)-cleared individually, or the kit must be 510(k)-cleared before such a constituent can be included.

Manufacturing of the individual constituents, as well as the kitting operations are both subject to the requirements of establishment registration and device listing in 21 CFR 807.  Also required are the GMP controls from 21 CFR 820.

Hope this helps,

I wanted to reach out to see if anyone could tell me the regulation to list an Infusion Starter Kit, and a Fresh Whole Blood transfusion set with Donor Set and Recipient Set.  Can the product be re-pack as a convenience kit and the Donor and Recipient Set  can be  also sell as an individual set. I wanted to check on the regulations to do so. Thanks for the guidance!

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------

I know of no U.S regulation specifically addressing the kitting of non-medical devices with medical devices.  Remember that, when it enforces medical device requirements, the FDA’s statutory authority and corresponding regulations are ultimately dictated by the definition of medical “device” from the FD&C Act.  Accordingly, there is no statutory basis for FDA to regulate the non-medical device constituents.  However, FDA will expect the manufacturer to be sure that the presence of the non-medical devices does not adversely affect the medical devices.  For example, 21 CFR 820.130 requires that the medical device packaging be designed to protect the medical devices from alteration or damage.  This means that the non-medical devices should be present during the medical device package integrity / shipping study.

Remember also that a first-aid kit is viewed by FDA as a medical device, and in particular, a convenience kit (per 878.4014).  Therefore first-aid kits are subject to the same requirements I described in my first comment in this thread.  Beware however that if drugs are present in the kit, then the drug constituents must also comply with the corresponding requirements of FDA’s CDER.

From mission-to-mission when kit consumables are used and restocked, the end user / purchaser is permitted to replenish the kit contents as needed by adding constituents purchased individually.  The end user / purchaser is not subject to medical device regulatory obligations when doing that.  But if the bags/kits are being returned to the manufacturer for restocking, then that is a more tricky scenario and would require careful consideration and process controls and GMP to assure that such further processing of the kit does not significantly affect the safety or effectiveness of any of the kit's components.  For example, such additional processing could disqualify the kit from the convenience kit exemptions and trigger the need for a 510(k).

Kevin, thank you so much for so a value feedback.

Is any regulation for military and law enforcement multi-mission bag and/or Individual First Aid Kit stock with  medical devices product and other accessories that are not medical devices? What about for restocking them or customer custom bags? Those bags contain class I and Class II devices but do I need to treat the bags as a medical device or as a first aid kit?

Based on the information you've provided, it appears that these devices would be regulated in the U.S. per 21 CFR 880.5440 as, but not necessarily limited to, product code(s) FPA, BRZ, and/or POQ. Additional details are needed to provide a conclusive regulatory assessment. But here is some general explanation that may facilitate related decision-making:

In general, when sold individually, the aforementioned product types require section 510(k) notification.  If already 510(k)-cleared individually, then they may be kitted together without additional 510(k)-clearance by applying the FDA's convenience kit guidance document (including careful attention to the limitations therein).  For example, if any kit constituent lacks its individual 510(k) clearance, then it must either first be 510(k)-cleared individually, or the kit must be 510(k)-cleared before such a constituent can be included.

Manufacturing of the individual constituents, as well as the kitting operations are both subject to the requirements of establishment registration and device listing in 21 CFR 807.  Also required are the GMP controls from 21 CFR 820.

Hope this helps,

I wanted to reach out to see if anyone could tell me the regulation to list an Infusion Starter Kit, and a Fresh Whole Blood transfusion set with Donor Set and Recipient Set.  Can the product be re-pack as a convenience kit and the Donor and Recipient Set  can be  also sell as an individual set. I wanted to check on the regulations to do so. Thanks for the guidance!

------------------------------
Brenda Miller
Combat Medical Systems
Harrisburg NC
United States
------------------------------