The new article provides extensive clarifications on labeling requirements to be followed in order to ensure all the vitally important information is duly communicated to end-users.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to radiation control regulations. The document is intended to provide additional clarification and recommendations to be taken into consideration by manufacturers of diagnostic X-ray equipment and other parties involved in order to ensure compliance with the regulatory requirements set forth under the existing legal framework.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the relevant legislation and has been agreed with the authority in advance.
General Labeling
The scope of the guidance covers, inter alia, a wide range of aspects related to labeling in the context of x-ray devices. In particular, in order to assist the parties involved, the authority provides answers to the most important questions associated with labeling requirements set forth under the existing legal framework.
Language of Labels:
Question: Must certification and identification labels be written in English?
Answer: Yes, certification and identification labels must be in English, though abbreviations like “Co.” and “Inc.” may include foreign equivalents (21 CFR 1010.2(b) and 1010.3(a)).
Component-Specific Labeling:
Question: Can labeling information be included in the user’s manual instead of on individual components?
Answer: No. Each certifiable component must have its own label for certification and identification (21 CFR 1010.2, 1010.3, and 1020.30(c)).
Question: Can a combination of certifiable components bear a single label?
Answer: Yes, but only with written FDA authorization. In some cases, such as inseparable high-voltage generators and beam-limiting devices, single labeling may be used without prior authorization (21 CFR 1020.30(c) and 1010.3(b)).
Requests for Single Labeling:
Question: How can a manufacturer apply for FDA authorization for single labeling?
Answer: Submit a written request specifying the components and justification to the FDA at the address provided in the guidance. Requests may also be submitted to the authority via email.
Evaluation of Single Labeling Requests:
Question: How does the FDA evaluate single labeling requests?
Answer: The manufacturer must demonstrate that the combination complies with performance standards under a testing program. Typically, the components should be contained in a single housing and marketed as a single entity (21 CFR 1010.2(c)).
Labeling Scenarios
The document further addresses certain specific scenarios, explaining the regulatory approach to be applied in each of them.
Subassemblies:
Question: Must each subassembly in a system have individual labels?
Answer: Not necessarily. A single model number may be assigned to multiple parts of a system if appropriate labeling is applied to the main subassembly performing the certified function (21 CFR 1010.3 and 1020.30(e)).
Computers as X-Ray Controls:
Question: Must laptops or desktops controlling x-ray systems be labeled?
Answer: Yes. These computers serve as x-ray controls and must meet labeling requirements, including certification, identification, and warning labels (21 CFR 1020.30(b)).
Labeling may include:
- Physical Labels: Placed on the hardware with instructions for verification.
- Electronic Labels: Displayed on-screen during system startup or use.
Symbols in Labels:
Question: Can manufacturers use symbols instead of text in labels?
Answer: Symbols from FDA-recognized standards like ISO 7000 may be used in certain cases but not for certification or warning labels, which must use complete English phrases (21 CFR 1020.30).
Label Location
Under the general rule, it is important to ensure that labeling does not only comply with the relevant requirements in terms of its content but is also placed appropriately, thus ensuring visibility.
Accessibility:
Question: Where should labels be located?
Answer: Labels must be legible and accessible without tools or relocating the system. If labels are behind panels or covers, instructions must indicate their location (21 CFR 1010.2(b) and 1010.3(a)).
Special Cases:
- Duplicate Labels: Duplicate labels on cosmetic covers are acceptable if the components themselves are labeled identically.
- Plastic Shields: Labels covered by removable shields must remain visible without tools, such as screwdrivers.
Question: Is label placement on components facing a wall acceptable?
Answer: No. Labels must be visible without obstruction.
Assembler Instructions:
Question: How can manufacturers ensure compliance during installation?
Answer: Provide clear instructions to assemblers on the proper placement of labels to maintain visibility post-installation (21 CFR 1020.30(g)).
Certification Labels
A special part of the guidance covers the aspects related to labels reflecting the certification status of a device.
Requirements:
Question: What wording is required for certification labels?
Answer: The exact wording is flexible but must clearly indicate compliance with FDA standards. Examples include:
- “Complies with DHHS radiation performance standards, 21 CFR Chapter I, Subchapter J.”
- “Product complies with applicable DHHS standards under Subchapter C – Electronic Product Radiation Control of Chapter V of the Federal Food, Drug, and Cosmetic Act.”
Date of Manufacture:
Question: Can manufacturers include “at the time of manufacture” on labels?
Answer: Yes, with clarifying language such as “in effect at the time of manufacture.”
Identification Labels
In accordance with the regulatory requirements set forth under the existing legal framework, labeling should also contain the information necessary to identify the device.
Manufacturer Information:
Question: What information must be included?
Answer: The full name and address of the certifying manufacturer, as well as the place, month, and year of manufacture (21 CFR 1010.3(a)).
Question: Can manufacturers use codes for the place of manufacture?
Answer: Yes, if the code is pre-approved by the FDA.
Alternate Identification Methods:
Question: Can a Uniform Resource Locator (URL) replace manufacturer details?
Answer: No, but manufacturers may add URLs in addition to the required information.
Warning Labels
Warning labels are vitally important as they communicate critical safety-related information. Considering this, the authority pays special attention to the way they should be used.
Control Panel Warnings:
Question: What wording is required on warning labels?
Answer: Wording depends on the date of manufacture. For devices made after June 10, 2006, the label must include: “Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions, and maintenance schedules are observed”.
Electronic Warning Labels:
Question: Can warning labels be displayed electronically?
Answer: Yes, on computerized control panels, provided they meet accessibility and visibility requirements during use.
Conclusion
In summary, the labeling requirements outlined in the present guidance are intended to ensure transparency, safety, and compliance for diagnostic x-ray systems. Manufacturers are obliged to follow these standards, provide clear instructions, and ensure all labels are accessible and legible throughout the product lifecycle.
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