The new article highlights the aspects related to the concept of commercial availability, problematic assembly situations, and temporary installations (for instance, in case one of the existing components needs to be repaired).
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 assemblers of diagnostic x-ray equipment. The guidance structured as a questions-and-answers document provides additional clarifications regarding 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 underlying legislation and has been agreed with the authority in advance.
The scope of the guidance covers, inter alia, the restrictions on the assembly of components (for instance, the ones related to compatibility), and also describes problematic assembly situations and temporary installations.
One of the concepts used in the context of components to diagnostic x-ray equipment the authority describes in the present guidance is“commercial availability”. As explained by the FDA, a component is “commercially available” if it can be supplied by any manufacturer within a reasonable time period. The document also answers the question of whether it is allowed to use the components for which there are no statements of compatibility in case there are no commercially available compatible components. In this respect, the authority states that certified components that are not compatible may not be interconnected without a variance from the Performance Standards.
Problematic Assembly Situations
As it was mentioned before, the guidance also provides recommendations to be considered in case of problematic assembly situations.
For instance, according to the guidance, should the instructions provided by the medical device manufacturer be confusing or incorrect, the assembler should reach out to the manufacturer and notify the latter accordingly, asking for clarification to be provided. Furthermore, such issues should be duly documented in the “Comments” section of the assembly report. In such a case, an installation should be postponed until clear instructions will be received from the manufacturer if due to the unclarity identified an assembled equipment could be deemed noncompliant.
Under the general rule, the assembler of the x-ray control is required to assemble, install, adjust, and test the certified component in accordance with the manufacturer’s instructions. Should it appear that the power indicated by the manufacturer is not available, the assembler is entitled to refuse to connect equipment to a power source present.
The scope of the guidance also covers the aspects related to temporary installations which could take place when a component of a diagnostic x-ray system should be removed to be repaired and, consequently, requires a temporary replacement. As explained by the authority, a compatible replacement component could be installed. It is important to mention that in case the initial component is certified, the replacement component should be certified as well. According to the guidance, upon installation of a certified loaner component, the assembler is not required to file a report of assembly provided the loaner component is (1) clearly labeled as a temporarily installed component and (2) bears a temporary tag or label with the statement signed and dated by the assembler affirming compliance with all applicable requirements of the Performance Standards. At the same time, it is important to mention that even in such cases a report is not required, the authority will consider them to be an introduction of the component, so the appropriate records should be maintained by the distributor.
The document also provides additional clarifications regarding the assembly reports and highlights the key points to be considered by assemblers when preparing such reports. According to the guidance, a report of assembly is a form (FDA 2579) to document that an assembler has installed the system or component according to the manufacturer’s instructions. As set forth by the applicable regulatory requirements, such a form should be completed by anyone who conducts the assembly of certified components of diagnostic x-ray systems. The authority also mentions that this requirement will be triggered irrespective of whether it is the entire system being assembled or only one component is installed. Furthermore, it is also stated that usually assembly conducted at the place of future use actually constitutes the last step in the manufacturing process. According to the guidance, the form serves as documentation that the equipment installed is certified, compatible with other components of the system, was installed and tested following the manufacturer’s instructions, and is of the type called for by the Performance Standards.
The said form could be downloaded from the FDA’s website.
As further explained by the FDA, there are certain exceptions when the report of assembly is not required. Such cases are described in regulation 21 CFR 1020.30(d)(2) and include, inter alia, the following ones:
- Installation of certified accessory components;
- Installation of original components after being repaired, irrespective of whether they have been removed from the system for repair, provided the initial installation has been duly reported;
- Temporary installation of components and their subsequent replacement with the initial ones.
In terms of the assembler’s responsibility, submission of an assembly report means that the assembler becomes responsible for ensuring that:
- The certified components are properly installed;
- Any and all instructions and recommendations provided by the manufacturers have been fulfilled;
- A copy of the form has been forwarded to all the parties involved, including the purchaser, and the state authority in the sphere of radiation protection.
In summary, the present FDA guidance provides additional clarifications regarding the specific aspects related to the assembly of diagnostic x-ray systems and reporting associated thereto. The scope of the guidance covers the aspects related to the concept of commercial availability, problematic assembly situations, and temporary installations. The document also describes in detail the requirements to be applied for assembly reports.
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