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 9
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
R Flammability requirements for applied parts as per 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Acquired Medical Device Product Line - Documentation Requirements for Device Master Record ISO 13485:2016 - Medical Device Quality Management Systems 7
D Customer requirements on specific standards Various Other Specifications, Standards, and related Requirements 4
S State Licensing requirements for Medical Devices sold in the US directly to hospitals and tissue banks 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R PPAP Requirements for Tool Repair or Refurbishment APQP and PPAP 5
I France clinical trial requirements EU Medical Device Regulations 1
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
H Electronic care product on patient bed side - Flammability requirements (62368-1) Hospitals, Clinics & other Health Care Providers 0
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
M GP-12 procedure form and requirements Customer and Company Specific Requirements 1
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
D Customer Specific Requirements / Customer Requirements for Indirect Customers IATF 16949 - Automotive Quality Systems Standard 10
J Print Requirements Manufacturing and Related Processes 9
S Requirements for Certificate of Destruction for Surgical Instruments Medical Device and FDA Regulations and Standards News 2
R FAI & P.O. Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
W MDD Distributor Registration Requirements Other Medical Device Regulations World-Wide 0
M FDA Requirements for Investigational Devices - Clinical Investigation & Shipping Medical Device and FDA Regulations and Standards News 0
B Requirements for LiPo Batteries in the EU ? CE Marking (Conformité Européene) / CB Scheme 7
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
A MDR - Legacy Device Review Timeframe and Requirements EU Medical Device Regulations 3
J Translation requirements for the statement referred to in ANNEX XIII of MDR EU Medical Device Regulations 0
D Hand Held medical device - power supply requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
J Gauge Management - with ambiguous requirements & no support ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
lanley liao How to understand and master the requirements of each section in API monogram product. Oil and Gas Industry Standards and Regulations 5
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
Y MDR requirements for Class I accessories EU Medical Device Regulations 2
K IATF audit day requirements table 5.2 IATF 16949 - Automotive Quality Systems Standard 6
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
C Requirements for distributors under MDR: translation EU Medical Device Regulations 0
D What are the acceptance criteria/requirements for Stability Study? General Measurement Device and Calibration Topics 7
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
Techilady Ford Special Characteristics Communication and Agreement Form (SCCAF) provides production requirements? FMEA and Control Plans 4
P Requirements for being an European Representative EU Medical Device Regulations 3
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
A GPS Regulatory requirements? Manufacturing and Related Processes 6
J SSQR-01 Vision Requirements- Color Blindness AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0

Similar threads

Top Bottom