What are the requirements for selling Alcohol Swabs in USA

[DannyK]

What are the requirements for selling alcohol swabs in USA?
I did a brief internet search and found a 510k summary that indicated that alcohol swabs are not classified.

Thanks in advance for your help!

Danny

 

[J0anne]

Re: Selling alcohol swabs in USA

Hello Danny. First you need to decide whether the swabs are medical devices or not. If they are, then classify them according to their intended use. They will most likely fall into the category of a Class I medical device that doesn't require a 510 (k)

 

[DannyK]

Thanks J0anne.
If it is considered as class 1- what steps need to be taken to sell it in the US?

 

[J0anne]

Thanks J0anne.
If it is considered as class 1- what steps need to be taken to sell it in the US?

Your device will be subject to general controls if it's Class I.

You can find all the info you need here http://goo.gl/YP6yrs

 

[Laura Halper]

Danny K,
As JOAnne said, the requirements depend greatly on the intended use. If the alcohol swabs are intended to be used to disinfect a person's skin (prior to injection, for example), then the FDA requires 510(k) clearance, even though the device is unclassified.

So if this is your intended use, you would need to obtain 510(k) clearance and also comply with the general controls (e.g., 21CFR 820 and regulations for Labeling, Recalls, and MDR reporting).

Laura

 

[MIREGMGR]

A search for "alcohol swab" at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm found the eight 510(K)s below:

Bd Alcohol Swab
Becton Dickinson & Co.
K121655
03/20/2013

Hexidis Alcohol Swab
Specialites Septodont
K910735
04/02/1991

Baxter Acetone-Alcohol Swabstick, Steril
Span-America Medical Systems, Inc.
K894791
10/03/1989

Quickpad (Alcohol Swabs)
Holtsch Co., Inc.
K892193
08/04/1989

Acetone Alcohol Swabs
Concord Laboratories, Inc.
K833936
01/30/1984

Alcohol Swabs
Concord Laboratories, Inc.
K833993
01/30/1984

Aplicare One Acetone Alcohol Swabstick
Aplicare, Inc.
K833183
10/31/1983

Aplicare Three Alcohol Swabsticks
Aplicare, Inc.
K833184
10/27/1983

All the ones I looked at are assigned into LKB, which is Unclassified, i.e. pre-1976. I'd think one of these could be your predicate, depending on your product characteristics.

what steps need to be taken to sell it in the US?

In addition to Joanne's and Laura's advice above, you of course have to Register the manufacturer or otherwise identify to FDA the manufacturing/marketing chain; and the parties involved in the manufacturing/marketing chain have to appropriately List the product.