Medical Device Labelling in 510k

Medical Device Labelling in 510k : Label is display of written, printed, or graphic matter upon the container of any article/medical device, it includes details like instructions for proper use, requirements for operating device safely, storage and maintenance and installation requirements, it also includes information that when particular medical device is put up for sale in the market. It must be clearly visible even if they contain is having any additional packaging. Medical labelling must follow instructions listed on FDA CFR 21 Part 801.

No false information should be displayed on label. In addition to this FDA requires that manufacturer use Unique Device Identification (UDI) labels. UDI on label must in both ways i.e., printed and machine legible. The purpose of UDI is it helps in tracking of specific device. For regulatory purpose in US items that are considered as labels are: advertising, instruction booklets, inserts, brochures, posters, and any similar materials.

FDA complaints that label must incudes following things:

  • Manufacturer’s name and business location.
  • Intended use of the device.
  • Adequate directions for a layperson to safely operates the device.

Why is medical device labelling important?

Patient and medical professionals need clear instructions, guidance, and warning of device to ensure safety and proper usage of the medical product. Many medical devices are designed that can be used at home by patients without supervision of medical professionals, if devices are misused or improperly handled, they may not be able to give accurate results and may cause harm to the user. Accurate labelling help to minimize bad experiences.

General guidelines for the medical device labelling.

Labelling of all medical devices is not same it depends upon various factors, so manufacturer ensures that all necessary information is include on label that gives clear direction and usage of product to the user. Proper symbols should be used with description that helps user to get clear image of the product.

General notes that should be included on medical device labelling

  • Risk/Benefit information
  • Instructions for use

Risk Benefit information: It is the information people need to decide to use device and have it or not. This information is regarding awareness of the potential risk that can occurs with device, it includes:

  • Detail information about what device is and what it is used for.
  • Restricted for specific type of population (any disease suffering person)
  • Risks and benefits to patients with device usage
  • Information on how to maintain device and identify potential problems with device.
  • Important information to enable person to make decision about the device.

When is medical device labelling not necessary?

Tools that are used by health care and practitioner these types of medical devises are not allowed to be used at home by patients, so labelling is not mandatory in such devices. E.g., of these types of devices includes blood pumps, scalpels, or other surgical instruments.

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