The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices.
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 diagnostic x-ray equipment. In particular, the document constitutes an assembler’s guide outlining the key points to be considered by the parties involved in operations with the said products. It is also important to mention the FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered in order to ensure compliance thereto. Moreover, an alternative approach could be applied, provided such an approach is in line with the underlying legislation and has been agreed with the authority in advance. 

The document is comprised of questions and answers provided by the authority to address the main concerns of the industry. In particular, it covers the most important matters related to the policy the authority intends to apply with respect to the devices falling within the scope of the guidance. 

Reporting Requirements 

The first question refers to the reporting requirements to be followed with respect to x-ray devices. According to the guidance, most of the requirements the assembler is bound by could be fulfilled by submitting a report of assembly (Form FDA 2579) and keeping a copy of it for a period of at least 5 years. Apart from that, assemblers are also obliged to notify the authority about any cases of accidental radiation occurrence they become aware of (both the actual and potential ones). 

An accidental radiation occurrence (ARO) is defined as a single accidental event or series of accidental events that has/have resulted in injurious or potentially injurious exposure of any person to electronic product radiation as a result of the manufacturing, testing, or use of an electronic product. The appropriate definition is provided by regulation 21 CFR 1000.3(a). Should an assembler become aware of a situation covered by the scope of the above definition, the appropriate reporting obligation will be triggered. In such a case, a notification should be duly submitted to the Center for Devices and Radiological Health (CDRH) electronically or via regular mail. Such a report should contain the following details:

  1. The nature of the accidental radiation occurrence,
  2. The location at which the accidental radiation occurrence occurred,
  3. The manufacturer, type, and model number of the electronic product or products involved, 
  4. The circumstances surrounding the accidental radiation occurrence, including causes, 
  5. The number of persons involved, adversely affected, or exposed during the accidental radiation occurrence, the nature and magnitude of their exposure and/or injuries, and, if requested by the Director, Center for Devices and Radiological Health, the names of the persons involved,
  6. The actions, if any, taken by the manufacturer, to control, correct, or eliminate the causes and to prevent reoccurrence, and 
  7. Any other pertinent information with respect to the accidental radiation occurrence. 

As further explained by the authority, in such cases, apart from the authority in the sphere of medical devices, an assembler should send the appropriate notifications to the user, the relevant radiation control authorities, as well as the manufacturer involved.

Components And Systems 

The scope of the guidance also covers questions related to components of x-ray medical systems. In this respect, the authority utilizes the term “certified components”, which refers to the ones that are specified components manufactured after an effective date (as published in the Performance Standards) that a manufacturer has designed, manufactured, and tested to meet the applicable requirements of 21 CFR 1020. As further explained in the guidance, it is the responsibility of the manufacturer to certify that the system will comply with any and all applicable requirements provided it has been installed and is being used strictly in accordance with the appropriate instructions provided by the manufacturer. According to the guidance, a certified system is one that is assembled of all certified compatible components that are designed to function together as a system meeting all applicable requirements in 21 CFR 1020. The document also provides a list of components that are subject to the Performance Standards. 

Under certain conditions, the one being the medical device manufacturer or acting in accordance with the instructions communicated by the latter may be entitled to make changes to x-ray systems or components thereof without triggering the reporting requirements related to the assembly. In particular, the authority states that certified components or systems may be modified, provided that the modification does not result in the failure of the x-ray component or system to comply with the Performance Standards; while modifications that adversely affect the compliance of a component or system are permitted only when a variance has been granted in accordance with the regulations. Thus, a product owner making changes to the system or components thereof will not be obliged the submit the report of assembly, provided such changes will not affect the product’s compliance with the applicable regulatory requirements. At the same time, there will be an obligation to keep the records, including the date and details of such modifications. 

The authority also explains that the term “repair” when used with respect to a certified component or system stands for the actions taken to bring a malfunctioning item back to the original manufacturer’s specification. 

In summary, the present FDA guidance highlights the aspects related to the reporting requirements the assemblers are subject to and also describes the approach to be applied with respect to modifications to certified systems and components thereof. The document also provides definitions of the most important concepts and terms used in this respect. 




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