The new article addresses FDA guidelines related to models and assembly procedures for diagnostic X-ray equipment, emphasizing unique model identification, assembly responsibilities, and compliance with regulatory standards.
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.
The guidance, structured as a questions-and-answers document, provides important information based on the relevant regulations.
Models
Unique Model Identification:
Question: Should each version of a component model have a unique model number?
Answer: Yes, if differences between versions affect structural or electrical design characteristics, including compatibility. Cosmetic differences, such as paint colors, do not require unique model numbers (21 CFR 1000.3(o), 1020.30(e)).
Alphanumeric Formats for Model Numbers:
Question: Can manufacturers use any alphanumeric format for model and serial numbers?
Answer: Yes, as long as the format is in standard English characters and ensures the uniqueness of the model and serial numbers for each component or certified system (21 CFR 1020.30(e)).
Assembly
In accordance with the relevant legislation, an assembler is anyone who assembles, replaces, or installs components into a diagnostic x-ray system. This includes system owners or their employees when they perform these activities (21 CFR 1020.30(b)). Assemblers must file Form FDA 2579 unless exempted (21 CFR 1020.30(d)).
According to the guidance, the relevant requirements set forth by Form FDA 2579 include:
- Used or Donated Equipment: Assemblers must file Form FDA 2579 when installing used or donated certified equipment.
- Date of Installation: The “date of installation” refers to when the system or component is released to the user for use on humans. Assemblers have 15 days after installation to complete and distribute Form FDA 2579.
The document further outlines the key responsibilities of the parties involved, namely:
- Manufacturers: Must provide clear instructions for assembly, installation, adjustment, and testing to ensure compliance with performance standards. These instructions must include descriptions of required tests and necessary equipment (21 CFR 1020.30(g)).
- Assemblers: Must perform and document all required tests as specified by the manufacturer. Failure to comply may result in regulatory action by the FDA.
Compliance with Line Voltage Requirements:
Question: Can a system be installed if the line voltage does not meet the manufacturer’s specified requirements?
Answer: No. Assemblers must adhere to the manufacturer’s instructions, including those specifying line voltage requirements. Noncompliant installations are not permitted (21 CFR 1020.30(g)).
Responsibility for Noncompliance:
The relevant regulations also establish the responsibility for the parties who fail to comply with the relevant requirements, such as:
- Improper Assembly: If noncompliance is caused solely by improper assembly or installation, the manufacturer is not responsible (21 CFR 1020.30(c)).
- Compliance Testing Issues: If the system fails compliance tests due to assembly issues that follow the manufacturer’s instructions, the manufacturer may be held accountable and required to address the issue (21 CFR 1003.10).
Special Cases in Assembly:
Question: Are alternative line voltage specifications acceptable in real-world installations?
Answer: Yes. Manufacturers may specify alternate line voltage regulations for real-world conditions, provided these specifications are validated and ensure compliance (21 CFR 1020.31(b)(2)).
Assembly Instructions and Required Information:
The document also highlights the aspects related to the way important information about the device and relevant assembly procedures should be communicated to the parties involved in order to ensure correct installation and proper functioning. In particular, it is stated that manufacturers must supply adequate instructions for assembly, installation, adjustment, and testing. Instructions must be sufficient to ensure compliance and must be made available at a cost not exceeding publication and distribution (21 CFR 1020.30(g)). If specific software is necessary, manufacturers must provide access to assemblers and others upon request. Costs may only cover publication and distribution (21 CFR 1020.30(g)). At the same time, ancillary software that is not essential for compliance does not need to be provided.
If assemblers do believe they lack adequate instructions, they should contact the manufacturer and, if unresolved, notify the FDA through the CDRH Device Allegation process. The FDA may evaluate the adequacy of the manufacturer’s instructions and take action if necessary.
Compatibility Between Components:
Manufacturers must specify compatible components when compliance depends on their integration. They are responsible for ensuring that compatibility does not interfere with compliance of the assembled system (21 CFR 1020.30(g)).
Conclusion
In summary, the relevant section of the guidance emphasizes the critical roles of manufacturers and assemblers in ensuring diagnostic x-ray systems meet FDA performance standards.
Key takeaways include:
- Models: Unique model numbers are required for components with different structural or electrical designs.
- Assembly: Assemblers must file Form FDA 2579 for all installations, including used or donated equipment, and follow detailed testing and installation instructions.
- Manufacturer Responsibilities: Manufacturers must provide adequate instructions and, when necessary, access to required software.
- Compatibility: Clear specifications for compatible components are mandatory to ensure system compliance.
These guidelines are intended to maintain safety, functionality, and regulatory compliance for diagnostic x-ray systems.
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