What are the requirements for selling Alcohol Swabs in USA

DannyK

Trusted Information Resource
#1
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
 
Elsmar Forum Sponsor
#2
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)
 
L

Laura Halper

#5
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
 
M

MIREGMGR

#6
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.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
B Additional requirements for selling Class I Medical Device in Poland EU Medical Device Regulations 3
G Selling a CE mark Class I Medical Device in Sweden - Any other requirements? EU Medical Device Regulations 13
C Labeling requirements when selling demo Medical Device equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
I Requirements for selling Class I Medical Devices in Canada ISO 13485:2016 - Medical Device Quality Management Systems 4
B Regulatory Requirements are for selling Medical Devices in the Ukraine? Other Medical Device Regulations World-Wide 9
Q Labeling requirements when selling products manufactured in China Various Other Specifications, Standards, and related Requirements 4
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
I Addiotional National requirements for placing MD in the EU countries EU Medical Device Regulations 4
G Tool tracebility and First calibration requirements for aerospace (AS9100) organisation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Managing How PPAP Requirements are Communicated in the Manufacturing Process and to Suppliers APQP and PPAP 4
T Controlled Forms or documented requirements for records? ISO 13485:2016 - Medical Device Quality Management Systems 2
E SIP/SOP requirements for USB port used for charging IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
L Exemption from the Regulation COVID-19 and QMS requirements EU Medical Device Regulations 2
A ANSI/AAMI versions of 60601-1-2 and related testing requirements Other Medical Device Related Standards 0
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S PSW - Requirements for "off-the shelf" component that has multiply manufacturing locations Off the Shelf Item Manufacturing and Related Processes 1
D IATF16949 - Interpretation of Customer Requirements clauses Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
S Customer Specific Requirements (CSR) not signed/approved IATF 16949 - Automotive Quality Systems Standard 17
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Non-EU Language Requirements Other Medical Device Regulations World-Wide 3
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
P Surgical masks ( type IIR) - Cleanroom Requirements EU Medical Device Regulations 3
K IEC 62304 - Functional and performance requirements for SOUP items IEC 62304 - Medical Device Software Life Cycle Processes 2
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
dgrainger Clue to UK's new regulatory requirements - approval of all devices placed on the market? Other Medical Device Regulations World-Wide 1
R Requirements for MDR Article 22 Systems EU Medical Device Regulations 1
shimonv Minimum 60601 requirements for a clinical trial IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K OEM specific requirements - PPAP was rejected by STA Customer and Company Specific Requirements 5
W Insulation requirements of BF type infant skin temperature probe IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
L FDA Biocompatibility Requirements - Transitory Contact Other US Medical Device Regulations 1
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S MDR GSPR Clause 17 - Software Requirements EU Medical Device Regulations 2
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
A Regulatory requirements for electrical cosmetic appliances US Food and Drug Administration (FDA) 5
M IEC 61000-4-2: Requirements for coating declared as insulating IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Requirements for "Claims Guide" for medical devices Medical Device and FDA Regulations and Standards News 6
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
R AS9100 - 8.4.2 - Receiving Inspection Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M Requirements for an MDD approved device after 26/05/2021 EU Medical Device Regulations 3
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3

Similar threads

Top Bottom