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Danny Kroo
ISO 13485 medical device, AS9100, AS9120 aerospace and ISO 9001 QMS consultant & lead assessor QA/RA Manager at Montmed
December 2018
What are the regulatory requirements for selling first aid kits in the USA?
< 1 min reading time

Hello everyone, what are the requirements for selling first aid kits in USA?

The first aid kits will include medical gloves, BZK swabs and alcohol prep pads and the suppliers of each will be FDA approved for these products.

What needs to be done to get clearance of the first aid kits?

Thank you in advance for your help!

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Posted by Danny Kroo
Asked on December 5, 2018 6:20 pm
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Private answer
Robert Packard

Hi Danny,
First aid kits are considered a convenience kit, and the FDA created a guidance document for convenience kits. The link for the guidance document is: https://www.fda.gov/RegulatoryInformation/Guidances/ucm080216.htm.
First aid kits are specifically listed as a kit under General & Plastic Surgery. In addition, you can also find three different product classifications for first aid kits: LRR - first aid kit with drug, OHO - first aid kit without drug, and OVR - talking first aid kit. These kits are exempt from 510(k) submissions, but if you include BZK swabs these are considered drugs that are regulated by CDER. Depending upon the concentration of ingredients and the claims the swabs may be an OTC product or a prescription-only product. Therefore, my advice is to make sure that the swabs are OTC swabs and compliant with the labeling requirements for an OTC swab.

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Danny-keep in mind, that if you repackage any drugs in your kit, that you are now subject to 21 CFR Part 210/211, and, even more ominous, unannounced FDA inspections. These inspections are burdensome, and 100 percent worse than device inspections. They do not annotate 483's, and worse, do not understand CAPA approaches to known non conformances. Often, on a 483, they will gig you for well understood non conformances, which are under strong CAPA control. The ambulance chasing websites will then glaringly put your 483 up on the web, and you are nakedly attacked for issues which are under control. My bigtime advice is to avoid drug additions to your kit if at all possible, or come up with a strategy to contain these horrendous CDER FDA inspectors. Even if you merely place OTC prepackaged drugs in your kit, you may now be subject to environmental controls possibly for the drug products. Also keep in mind all 50 states have quite serious State Pharmacy laws for drug shipped to their states.

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Danny Kroo

Thank you for the insight.

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Carolyn Jackson

The first aid kit that we are considering selling will have alcohol swabs as well as Sting Relief. I am trying to find out if I will need the FDA registration. without knowing what the customer will use the alcohol swab for I think that I should get it taken care of to be on the safe side. Please let me know what you think.

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