The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
Table of content
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 radiation control regulations. The document is intended to provide additional clarification and recommendations to be taken into consideration by manufacturers of diagnostic X-ray equipment and other parties involved in order to ensure compliance with the regulatory requirements set forth under the existing legal framework.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they 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 relevant legislation and has been agreed with the authority in advance.
Component and System Certification
According to the guidance, diagnostic x-ray equipment certification generally follows a component-by-component approach.
Manufacturers can:
- Certify individual components.
- Certify a complete system.
- Certify a combination of components with prior authorization from the FDA’s Center for Devices and Radiological Health (CDRH) Director (21 CFR 1020.30(c)).
The certification applies to components identified under 21 CFR 1020.30(a)(1)(i) and is required for introducing these components into commerce. These components may also qualify as medical devices under the FD&C Act and be subject to additional requirements.
Certification must occur before delivery to a distributor or dealer. Certification ensures compliance with applicable performance standards under Section 534 of the FD&C Act (21 U.S.C. § 360kk).
The document also answers the question if certifiable diagnostic x-ray components that are not certified can be imported. It is stated that under the general rule – no, however, under certain conditions, FDA permits importation for research, training, or reconditioning purposes via Form FDA 2877 – Declaration for Imported Electronic Products Subject to Radiation Control Standards.
These components must not be introduced into commerce until compliant or must be destroyed/exported after their purpose is fulfilled.
Special Considerations
The document further provides additional clarifications to be taken into consideration by x-ray manufacturers in the format of questions and answers.
Investigational Device Exemptions (IDEs):
Question: If a certifiable x-ray system is installed for investigational use on humans under an IDE, must it be certified?
Answer: Yes, systems under an IDE must comply with applicable standards and be certified (sections 538(a)(1) and (5) of the FD&C Act).
Post-Sale Responsibility:
Question: Who ensures compliance after a diagnostic x-ray system is sold and installed?
Answer: The certifying manufacturer is responsible for designing systems that remain compliant throughout their lifespan when properly maintained. Noncompliance caused by improper installation or maintenance by third parties does not hold the manufacturer liable (21 CFR 1020.30(h)).
Non-Human Applications:
Question: Does x-ray equipment for non-human use (e.g., veterinary, laboratory, or training purposes) require certification?
Answer: No. Such systems are not diagnostic x-ray systems and are exempt from certification. However, they are subject to general Radiological Health Regulations and reporting requirements (21 CFR 1002.1).
Mobile Diagnostic X-Ray Systems:
Question: Are there specific requirements for x-ray systems in mobile vehicles?
Answer: No specific regulations exist. Manufacturers should provide installation and maintenance instructions to address potential adverse environmental conditions.
Redefined or Modified Functions:
Question: If a component is modified to perform a function characteristic of a certifiable component, must it be certified?
Answer: Yes. Any modified component performing a certifiable function must meet applicable performance standards and certification requirements (21 CFR 1020.30(c)).
Examples include:
- Software Controlling Technique Factors: Considered an x-ray control and must meet standards for such components.
- Additional Accessories (e.g., front panel for digital detectors): Considered certifiable and subject to relevant standards.
Providing Compatibility Information:
Question: Must manufacturers provide compatibility details for their components?
Answer: Yes. Manufacturers must supply specifications for compatible components to ensure system compliance. This information may include physical characteristics or compatible model numbers (21 CFR 1020.30(g)).
Image-Guided Radiation Therapy:
Question: Do performance standards apply to x-ray image-guidance used in radiation therapy devices?
Answer: If the guidance system is solely for assisting radiation therapy and not for diagnostic imaging, it is exempt from 21 CFR 1020.30 but remains subject to other EPRC requirements. FDA recommends evaluating safety and performance using IEC 60601-2-68 standards.
Cone-Beam Computed Tomography (CBCT):
Question: Do CBCT systems conform to computed tomography (CT) standards?
Answer: Yes, CBCT devices are considered CT systems and must meet CT performance standards (21 CFR 1020.33). If certain provisions are unsuitable for CBCT, manufacturers can apply for a variance under 21 CFR 1010.4.
Conclusion
In summary, the present guidance emphasizes the critical role of certification in ensuring compliance with performance standards for diagnostic x-ray systems and components. Manufacturers must account for specific use cases, provide detailed compatibility information, and ensure maintenance instructions support long-term compliance.
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