Radiation-emitting product labeling applies to all products that produce sonic, infrasonic, or ultrasonic radiation. This labeling regulation is applicable in conjunction with general labeling requirements. These regulations cover only the parts of specifications that is related to product labeling. It does not address any of the standards' technical requirements. As a result, labeling requirements may not be the same as those outlined in general device labeling requirements.

General Labeling Requirements for Electronic Products

Manufacturers must give the following information on a tag or label permanently affixed or written on the product and visible when fully assembled:

  • A declaration that products meet the performance requirement
  • Manufacturers name and address
  • If the distributor uses a different manufacturer for each model of product, the name and address of each manufacturer must be included on the label. However, if the manufacturer has previously identified themselves to the Director of the CDRH, their name and address may be omitted from the label
  • Abbreviations such as Co., Inc., or their international equivalents, as well as the initials of people's first and middle names, may be used
  • The place, month, and year of manufacture
  • If the code has been previously submitted to the Director of CDRH, the site of manufacture may be indicated in a code
  • The manufacturing month and year cannot be coded or shortened. It must follow this pattern “MANUFACTURED: (Insert Month and Year of Manufacture)”The Director of CDRH may approve a request for an alternative form of identification if it is not practical to apply identification labeling in accordance with the requirements listed above.
  • The manufacturer of an EPRC product should provide Director of CDRH with a complete listing of all brand names and the names and addresses of the individuals
  • Products that are to be exported must have that inscribed on labels

Ionizing Radiation Emitting Products:

  1. Television receivers

    Any receiver that emits more radiation than the minimum requirement due to component failure or poor adjustment must include a permanently affixed or inscribed warning label according to regulations. The label must state the specification of high voltage and include instructions for adjusting the voltage to the appropriate value.

    This standard is applicable to products such as television receiver which works on closed circuit, computer monitors which display graphical image. Exception being monitors that display solely alpha-numeric characters.

  2. Cold Cathode Gas Exchange Tubes

    This standard applies to cold-cathode discharge tubes, these devices are used show the effects of an electron flow or the generation of X-rays.

    • For each tube, manufacturers must give necessary safety instructions, operating instructions, and power supply requirements.
    • Each enclosure or tube must have permanent polarity labeling of the terminals.
    • Tubes intended for heat, fluorescence, or magnetic effect must include a warning that excessive power application may result in x-radiation.
    • Tubes built for x-rays must indicate a warning when the instrument emits X-rays.
    • The relevant tags or labels must be visible when the gadget is fully built and ready for use.
  3. Diagnostic X-ray Systems

    The control panel having the main switch, temporarily installed compatible components and, temporarily installed noncompatible components must bear warning statements as specified by USFDA.

    This specification applies to computed tomography (CT) and diagnostic X-ray systems created before November 29, 1984.

  4. Radiographic Equipment
    • When more than one X-ray tube is used from a control, the THA or a nearby area near it must be indicated before exposure as to which tube is being used.
    • The override key or switch must be labelled: FOR X-RAY FIELD LIMITATION SYSTEM FAILURE if the equipment can bypass positive beam limitation (PBL) in the event of a system failure.
    • The technique factors must be mentioned before exposure.
    • Each fixed aperture, beam limiting device must have permanent labels indicating the image receptor size, SID, and, if relevant, which aperture is in the open position for operation.
    • If the spot-film device can override the system's automated X-ray field size adjustment, the override switch must be marked "FOR X-RAY FIELD LIMITATION SYSTEM FAILURE."
    • General purpose stationary systems must display field size dimensions and operational SIDs.
    • When the X-ray beam axis is perpendicular to the IR, SGF systems must signal this.
  5. Fluoroscope equipment
    • The potential and current of the X-ray tube must be displayed.
    • If the device can manually change the X-ray field size case of a system failure, the override switch must be marked "FOR X-RAY FIELD LIMITATION SYSTEM FAILURE."
  6. Cabinet X-ray systems
    • From each door, access panel, and port, at least one indication with the label "X-RAY ON" must be visible.
    • If a cabinet X-ray system is meant to admit humans, the following must be on labels:
      1. Any controls that can start X-ray generation must be marked:
      3. This warning sign must be prominently displayed on port: "CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGISED - X-RAY HAZARD."

Light emitting products

  1. Lasers- are machines that can generate powerful radiation at a particular wavelength for both industrial and medical uses. Lasers need labels that specifically describe their kind, class, wavelength, and output power in addition to the general labelling requirements.
  2. Sunlamp – Used to induce skin tanning, they emit radiation in the wavelength range of 200 to 400nm in air.
  3. It must have a warning statement stating all the dangers of overexposures and risk of developing skin cancer and eye injuries if the procedure is not carried out without safety precautions.
  4. Additionally, it must contain the following information:
    1. On recommended position for exposure and directions to achieve it.
    2. Exposure schedule and time it will take for results to appear.
    3. UV lamp type used in product.
  5. UV Lamps- Label must include the following words-
    1. The words: "Sunlamp - DANGER - Ultraviolet radiation. Follow instructions.”
    2. The model number, and "Use ONLY in fixtures equipped with a timer."

Ultrasonic Radiation emitting products.

In addition to general labeling requirements the following should be inscribed on the label:

  • Operation controls
  • Service controls with statement “Service adjustment only”
  • Generator Label- Brand name, model designation, serial number, or other unique identification; the generator for which the applicator is intended; and the ultrasonic frequency, effective radiating area, maximum beam non-uniformity ratio, and kind of applicator.
  • Operation Manual- Must include:
    • assembly, operation, IFU, safety procedures, precautions, and maintenance schedule.
    • The geographical distribution of the ultrasonic radiation field and its orientation about the applicator.
    • The magnitude uncertainty in various parameters in relation to ultrasonic energy to be described.
    • Statement- "Caution: Using controls or adjustments or performing procedures other than those specified herein may result in hazardous ultrasonic energy exposure”.

Understanding the USFDA labelling standards for radiation-emitting equipment is critical for customer safety. Consumers can make informed judgements about product use when they have access to clear and accurate information. Manufacturers who follow guidelines preserve their clients health and safety. Compliance with the most recent rules is critical for maintaining consumer trust.

If you are a manufacturer of radiation products and looking to ensure consumer safety and uphold your brand trust. Look no further as Freyr can make sure that your products comply with all the USFDA regulations. To find out more about our regulatory consulting services and how we can assist you in achieving compliance, contact us.



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