The new article pays special attention to the situations when reports of assembly are not required and also provides additional recommendations regarding their content.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document addressed to the parties involved in the assembly of diagnostic x-ray medical devices. The guidance provides an overview of the applicable regulatory requirements, as well as recommendations to be considered 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 guidance is structured as a questions-and-answers document and provides additional details regarding the most important matters raised by the industry.
Submission of the Report
The document describes, inter alia, the cases when the report of assembly should be submitted.
For instance, in case the elements intended to be used for demonstration purposes will be temporarily installed in the diagnostic x-ray system, from a regulatory perspective such action will be considered as a temporary installation of the loaner. For the purpose of the guidance, “temporary” stands for a period of time not longer than 30 days from the date of installation. Hence, a standard report of assembly will not be required. At the same time, FDA also mentions that the relevant authority in the sphere of radiation protection may apply a more stringent approach. Furthermore, the general obligations of all the parties involved remain applicable as well.
Apart from that, the authority describes the cases of reinstallation of a required certified component. According to the guidance, in such a case, an assembler’s report will not be required, provided the same component has been reinstalled after being repaired. At the same time, in case of a new component being installed, the appropriate reporting requirements will be triggered, even if the component is replaced by an exact match. The authority also mentions that the existing regulatory framework provides certain exclusions from the said requirements (for a specific type of devices).
When describing the reporting requirements for digital image receptors, the authority mentions that the appropriate report should be submitted.
Another important aspect addressed in the guidance relates to errors or mistakes taking place during the assembly. As explained by the authority, in such a case, the assembler should make the necessary changes and explain the changes in the “Comments” on the copy of the form FDA 2579, copy the form, and distribute copies to the purchases, and, where applicable, to the State agency responsible for radiation protection.
Completing the Report
The guidance also provides additional clarifications regarding the way the report of assembly should be completed. For instance, the authority explains the difference between the concepts of “assembly” and “reassembly”, describing the situations in which each of these terms should be used. According to the guidance, “assembly” means the installation of an unused system or unused component into a system, while “reassembly” stands for the installation of a group of components (including any new upgrade components) that were previously assembled and used as an “x-ray system”. At the same time, it is also important to mention that there is no such distinction under the Performance Standards – the latter refer to the term “assembly” for both cases.
In order to assist assemblers in completing the appropriate report, the document also provides additional clarifications regarding the information to be reflected in the main sections of the assembly report as per the form. According to the guidance, the said form should include, inter alia, the following details:
- Information about the location of the equipment in question, including the address;
- Indication of a status, e.g., “new assembly”, “reassembly”, or “reassembly – mixed system”;
- Details about the intended uses (here the assembler will have to select all the relevant items from the list describing the intended use of a system in question);
- Information about the components of the diagnostic x-ray system being installed, including the details about the manufacturer, serial and model numbers, manufacturing date, and key technical characteristics;
- Details of an individual responsible for installation, calibration, and testing of the equipment in question (even more than one involved, only one name should be indicated);
- Date when the form has been signed by the abovementioned responsible person;
- Additional comments the assembler deems necessary to provide in order to reflect additional aspects that could be important for the authority to be aware of (e.g., any issues identified in the course of assembly).
The authority additionally emphasizes the importance of including accurate and relevant information about the assembler in the report. According to the guidance, details about the contractual relationship between the assembler and another entity involved (healthcare facility) should be provided as well.
In summary, the present FDA guidance describes in detail the regulatory requirements to be considered with respect to the assembly of diagnostic x-ray systems. The document outlines the responsibilities of assemblers and also provides additional clarifications regarding the approach to be applied when determining whether the report of assembly is required in each specific case or not.
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