Labeling requirements of Alcohol (Isopropanol) Swabs

B

Brad Oh

#1
Hi, All

is there any specific regulation that I could refer regarding Alcohol swab Labeling?

I am wondering if the package labeling need to indicate the volume of alcohol(Isopropanol) and swab's size.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
First a definition is needed:

1. What is the relevant regulatory domain (USA, EC etc.)?
2. What is the intended use of the swab?
 
B

Brad Oh

#3
here is the answer for your question.
1. domain is EC. if there is regulation for US FDA, it is OK. we just want to know there is guideline or regulation for Alcohol swabs labeling (i.e : what information should be included in the labeling)

2. intended use - Topical antiseptic for preparation of the skin prior to puncture or injection.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
here is the answer for your question.
1. domain is EC. if there is regulation for US FDA, it is OK. we just want to know there is guideline or regulation for Alcohol swabs labeling (i.e : what information should be included in the labeling)

2. intended use - Topical antiseptic for preparation of the skin prior to puncture or injection.
Hi,

According to this page, the FDA does not exercise its powers over alcohol swabs any more.

In the EC, there are typically no specific requirements for low risk devices. You should be meeting the applicable Essential Requirements, namely look at ER 13 (MDD annex I).

Cheers,
Ronen.

PS: If you run an image search for "alcohol swab" you will see many items where the individual pouch doesn't state either the alcohol volume or the swab's size; including ones that bear the CE mark; including ones from leading brands (e.g. BD).
 
Last edited:
Thread starter Similar threads Forum Replies Date
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
T Labeling Requirements - Creams in tubes EU Medical Device Regulations 3
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
I Requirements for different Labeling Levels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J FDA regulations vs. IEC 60601-1 Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
J ITA (Investigational Testing Authorizations) - Labeling requirements Canada Medical Device Regulations 1
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S Labeling requirements for procedure pack 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S Labeling Requirements for Acquired Medical Device Inventory Other US Medical Device Regulations 2
B Labeling requirements for Servicing and Repairing Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 2
F MDD Article 12 Labeling Requirements for CE Marked Medical Device - Help CE Marking (Conformité Européene) / CB Scheme 4
Z Labeling Requirements for Free Samples supporting Clinical Evaluation EU Medical Device Regulations 2
D Sterile Medical Device Temperature and Humidity (Storage) Labeling Requirements EU Medical Device Regulations 5
JoCam Labeling Requirements for Medical Devices Made in China EU Medical Device Regulations 6
A Japan Medical Device Labeling Requirements Japan Medical Device Regulations 5
G Labeling requirements for individual units for medical devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
S GHS Labeling Requirements question Occupational Health & Safety Management Standards 6
Q CE-Labeling requirements: Year of manufacture for Software EU Medical Device Regulations 3
F 2015 Sudan Medical Device Registration and Labeling Language Requirements Other Medical Device Regulations World-Wide 3
J Medical Device Labeling and Symbols - US and EU Requirements CE Marking (Conformité Européene) / CB Scheme 6
D Automotive Labeling Requirements for LH and RH Parts IATF 16949 - Automotive Quality Systems Standard 4
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
R Labeling, translation requirements including software interface: EU & other markets EU Medical Device Regulations 2
B Brazil ANVISA Medical Device Labeling/IFU Requirements Other Medical Device Regulations World-Wide 1
N Labeling Requirements for Medical Devices in Hong Kong Other ISO and International Standards and European Regulations 2
Y Labeling requirements for X-ray detector Other US Medical Device Regulations 1
S Class I Device - Reusable Instruments labeling requirements Imported Legacy Blogs 2
J IEC 60601 Third Edition Labeling Requirements - Section 5.2.2.1 (g) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Measurement Equipment Shelf Rack Labeling Requirements question General Measurement Device and Calibration Topics 5
N DEHP/DHP Labeling Requirements TGA Other Medical Device and Orthopedic Related Topics 2
T IEC 60601 3rd Labeling Requirements and Software GUI IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
P Thailand Medical Device Labeling Content Requirements Other Medical Device Regulations World-Wide 3
G Labeling Requirements - Medical Device is Rx in USA, non-Rx in EU 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
K Class Ins CE Mark Labeling Requirements (particularly Lot or Batch symbol and number) EU Medical Device Regulations 7
W Calibration and Measuring Device Labeling Requirements Quality Manager and Management Related Issues 4
Y Medical Device Accessory Labeling Requirements Other Medical Device Regulations World-Wide 1
L Labeling Requirements in Part A Class IIb Medical Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
T Requirements for Private Labeling a Class III (PMA) Medical Device in the US 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
C Indian Labeling Requirements for Imported Medical Devices Other Medical Device Regulations World-Wide 9
L Medical Device Battery Labeling Requirements in the US US Food and Drug Administration (FDA) 1
J Own Brand Labeling NB (Notified Body) requirements EU Medical Device Regulations 3
M 21CFR820.120 Device Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T FDA Labeling Requirements Vs Health Canada Requirements Other US Medical Device Regulations 5

Similar threads

Top Bottom