The article covers the key points related to the existing regulatory requirements and highlights the most important aspects to be considered by the parties involved.

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document constituting an assembler’s guide to diagnostic x-ray equipment. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are 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 existing legislation and has been agreed with the authority in advance. The present document constitutes a revised version of the guidance initially issued in May 2011.

​Regulatory Background 

First of all, the authority provides an overview of the current legislation creating a basis for the existing legal framework for diagnostic x-ray medical devices. According to the guidance, it is comprised of the Radiation Control for Health and Safety Act of 1968 later incorporated into the Federal Food, Drug, and Cosmetic (FD&C) Act by the virtue of the Safe Medical Devices Act of 1990. The relevant aspects are addressed in regulation 21 CFR Chapter I, Subchapter J, and the Diagnostic X-ray Performance Standards for Electronic Products. The regulations mentioned hereabove are addressing the matters related to the manufacturing, importation, and installation of radiation-emitting devices. Device-specific requirements are set forth by regulations 21 CFR 1020.30 “Diagnostic x-ray systems and their major components”, 21 CFR 1020.31 “Radiographic equipment”, 21 CFR 1020.32 “Fluoroscopic equipment”, and 21 CFR 1020.33 “Computed tomography (CT) equipment”. 

Furthermore, the present guidance refers to the Performance Standards, which are the Performance Standards for Diagnostic X-Ray Systems and Their Major Components. 

At the same time, the authority explicitly states that the scope of the present guidance covers only the requirements set forth under the EPRC provisions contained in the FD&C Act, while the requirements prescribed by the general medical device provisions of the said Act are falling outside the scope of the present guidance. 

In order to ensure compliance with the applicable regulatory requirements, medical device manufacturers involved in operations with x-ray products are obliged to ensure compliance with any and all relevant requirements introduced under the aforementioned regulations and standards. They are also obliged to place the appropriate labels confirming that the product has been certified. The authority also mentions that sometimes diagnostic x-ray systems are comprised of components manufactured by different entities, so their proper functioning, when used together, is vitally important, as well as the installation and final testing to be conducted before the system will be used for its intended purpose. 

Responsibilities of Manufacturers of Diagnostic X-Ray Equipment

The document further outlines the main responsibilities of the parties involved in manufacturing x-ray systems. In accordance with the applicable regulations, they include obligations to:

  1. Certify that each component complies with the Performance Standard. By the virtue of certification, the manufacturer confirms that the products will operate as intended and will comply with the applicable regulatory requirements when being used for their intended purpose, provided it is properly assembled and tested.
  • Place certification and identification labels complete with the full name and address of the manufacturer, date, and place of manufacture, model designation, and serial number on each component.
  • Provide the assembler with instructions for assembly, installation, adjustment, and testing of the component adequate to assure the product will comply with the Performance Standards when the instructions are followed. The authority additionally emphasizes that the said instructions should also contain information with respect to components to be used in order to ensure compatibility and proper operations of the diagnostic x-ray system. The information about compatible components could be provided in the form of a description of characteristics, or a s a list of specific components with the indication of model and manufacturer.
  • Provide the purchases with instructions describing specific technical specifications of the equipment and any necessary radiological safety precautions and procedures. As explained by the FDA, this should include the details of the recommended maintenance schedule to be followed by the parties using the device in order to ensure its continued compliance with the applicable regulatory requirements and Performance Standards.


General Responsibilities of Assemblers

The scope of the guidance also covers the aspects related to the responsibility of assemblers. According to regulation 21 CFR 1020.30(b), the assembler stands for any person engaged in the business of assembling, replacing, or installing one or more components into a diagnostic x-ray system or subsystem; the term includes the owner of an x-ray system or his or her employee or agent who assembles components into an x-ray system that is subsequently used to provide professional or commercial services. The authority also mentions that the above definition could be applied even to the ones for whom the assembly of diagnostic x-ray systems is not an ordinary business.

Even though there is a certain overlap between the concepts of the “assembler” and “manufacturer”, the current regulatory framework provides separate requirements for each of them. In particular, the responsibilities of assemblers are to be followed by all the parties assembling diagnostic x-ray systems to be used for humans.

The applicable regulations provide that assemblers are not responsible for compliance of the components used with the applicable regulatory requirements. At the same time, they are obliged to fulfill the reporting obligations with respect to an assembly conducted.

In summary, the present FDA guidance provides an overview of the existing regulatory framework for diagnostic x-ray equipment being radiation-emitting products. The document also highlights the key points to be taken into consideration when outlining the responsibilities of the parties involved, including medical device manufacturers and assemblers.



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