Medical Device Labels


FDA guidelines regarding Medical Device Labeling

A medical device label includes important information for the caregiver or patient. A medical device label consists of -
  • Supplier identification (for example, name and address of the device manufacturer)
  • Ideal and/or mandatory storage conditions
  • Specific properties of the device (for example, sterile)
The medical device label provides critical benefit/risk information and clear instructions for proper and safe usage. The labels are available in varying formats such as leaflets, brochures, videotapes, and more.

Are you searching for a reputable and reliable business to support your need for different kinds of medical device labeling? Kieran Label Corporation (KLC) can help with all your medical device label needs.

We provide medical device label services configured to match your individual needs, industry regulations and any unique specifications. Our professional production team works diligently to provide precise labeling for all medical devices.

General Medical Device Labeling Needs

Basic labeling provisions

The basic label needs for medical devices are dictated by FDA - 21 CFR Part 801. These regulations determine basic information that must be supplied on all medical devices.

Name and location of the company (21 CFR 801.1)

The labels should contain the name and location of the manufacturers, packer, and distributors including the street address, state, city, and zip code.

If the street address of the business is in the city telephone directory then the street address can be excluded.

Adequate instructions/directions (21 CFR 801.5)

The adequate directions for use section includes important instructions such that a layman can use the device safely for its designated purposes. This contains:
  • Conditions and purposes where medical device can be used
  • Dosages for every type of individual (doses for people with varying physical conditions and ages)
  • Timing of the application
  • Frequency of administration
  • Method or mode of application
  • Other factors affecting the duration of use
  • Any other important instructions for using the device

Misleading or false statements (21 CFR 801.6)

A medical device is considered misleading if it makes false statements about the food, drug, or cosmetic.

Prominence of statements (21 CFR 801.15)

A statement, word, or other required data can lack the required conspicuousness and prominence for several reasons:
  • Insufficient space for necessary labeling due to other  labeling on the package
  • Failure to display required information and warnings
  • Style of type, with insufficient space or poor contrast between package background and label text
  • Overcrowded or poorly designed labels which may be not legible or confusing

Exemptions

Exceptions can be allowed in situations where medical device does not have enough space for necessary labeling provided that:

Existing label space is not used solely for foreign language translations

If any foreign language is displayed on the medical device labeling, all required materials shall also display in that language as well

Kieran’s Label Medical Device Labeling Services

Our label process is predicated on achieving the goals and needs of our customers. Our services include:
  • Accurate, proper, and valid customer-supplied product information
  • Catalog numbers
  • UDI (Unique Device Identification) compliant barcodes
  • Instructions
  • Logos
  • Specifications of the materials
  • Serialization
  • Identifying information

A Trusted Name for Medical Device Labeling Needs in California

Kieran Label Corporation is just a phone call away from you. Pick up your phone, dial our contact number, and let us help you with all your medical devices labeling requirements. Our contact telephone numbers follow:

(619) 449-4457

(800) 227-8108 toll-free inside California

(800) 556-2600 toll-free outside California

No matter how complex or varied your needs are, we promise to help you find the best label solution for your medical devices and fit within your budget. For additional information about our medical device labels, talk to our representatives today!
1-800-556-2600