The new article provides additional clarifications regarding the aspects related to specific cases when assembly reports are required or not required
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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document intended to provide assemblers of diagnostic x-ray equipment with additional recommendations to be considered in order to ensure compliance with the applicable regulatory requirements set forth under the existing frameworks. At the same time, it is important to mention that the document is non-binding in its legal nature, nor is intended to introduce new rules or impose new obligations, but rather to provide additional clarifications. 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 scope of the guidance covers, inter alia, the aspects related to the reports of assembly to be submitted by the parties involved in the assembly of diagnostic x-ray systems before they will be used.
Assembly Reports: Specific Aspects
Under the general rule, every manufacturer of a certified component is required to state the compatibility requirements with other components that may be included in a final assembled system; the type required by the manufacturer(s) means that assemblers must meet these compatibility requirements when matching components for a complete system.
The authority additionally emphasizes the importance of paying attention to the intended purpose of the product in question, which could be either for “general purpose x-ray systems” or “other than general purpose”. The document provides a list of such special purposes as set forth by regulation 21 CFR 1020.31. The authority also mentions that computer topography (CT) systems are not considered general-purpose radiographic systems; any x-ray system, other than a CT system, which by its design is not limited to radiographic examination of a specific anatomical region and does not meet the requirements listed above, is considered to be “general purpose” for the purposes of 21 CFR 1020.31.
Filing and Assembly Report
The document further describes in detail the situations when the requirement to file a report of assembly will be triggered. In this respect, the authority mentions the following:
- In the case of installation of certified x-ray components and systems in veterinary facilities, filing of an assembly report will not be required – in accordance with the applicable regulatory requirements, it will be required only for the products intended to be used in humans. Thus, veterinary equipment does not require certification to the Performance Standards, but certified equipment is often installed in veterinary facilities. At the same time, the authority mentions that local authorities could apply different requirements, which might be more strict, so it is the sole responsibility of an assembler to ensure compliance thereto.
- In case of diagnostic x-ray equipment being removed entirely with no replacement, there is no need to submit any report. However, in some states, this will require a notification to be submitted to the responsible bodies.
- In case certified components are being moved from one system to another within the same healthcare facility, a report of assembly would still be required. At the same time, this will not apply in the case of certified accessory components – they could be moved between the systems without the reporting requirements being triggered, provided the initial installation was reported in a report of assembly.
- As it was mentioned before, in case of a temporary component being installed, a report of assembly is not required. The same applies when the original component is reinstalled. However, the authority additionally emphasizes that even though the report of assembly is not required, the FDA considers the installation of a certified loaner component to be the introduction of the component into commerce, and the dealer, distributor, and manufacturer are still required to maintain all of the records required under 21 CFR 1002.40. Furthermore, it is also stated that in case of a certified loaner is replaced with an entirely new component intended to stay in the system in the future, a report of assembly should be submitted.
- Reinstallation of a repaired certified component to the same system will not trigger the reporting requirements. At the same time, its installation to a different system will require a report of assembly to be submitted. The same applies in the case of the initial component being replaced with another one, even being of the same type. The authority also mentions that certain exemptions apply – to specific types of products.
- If the diagnostic x-ray system being assembled is self-contained (e.g., mobile, portable), the applicability of reporting requirements should be assessed on a case-by-case basis. Even though in most cases filing a report of assembly will be required, such a report is not needed in case of systems that are ready for use without any assembly (this should be clearly stated by the manufacturer). In the latter case, the medical device manufacturer will be responsible for certifying the system and ensuring its compliance with any and all applicable regulatory requirements. Ready-to-use system will be subject to testing only, with no assembly required.
- Filing assembly reports will be required in all the cases when diagnostic x-ray systems are being installed irrespective of whether the transfer of title takes place (for instance, in case the system of components thereto are leased or loaned to a healthcare facility to be used for a definite period of time). The authority explained that in such cases the system undergoes an ordinary installation process, so the general reporting requirements will apply.
In summary, the present FDA guidance provides an overview of the regulatory requirements associated with diagnostic x-ray systems in terms of their assembly. The document clarifies certain important aspects related to the reports of assembly and also describes the cases when the filing of a report of assembly will or will not be required.
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