The article addressed the key points related to x-ray medical devices in the context of applicable standards.
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 medical x-ray imaging devices in the context of conformance with IEC standards. The document describes the approach to be followed in order to ensure compliance with the applicable regulatory requirements and also provides additional clarifications and recommendations to be considered by the parties involved. 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 respective regulatory requirements and has been agreed with the authority in advance.
The present FDA guidance describes the policy the authority intends to apply with respect to medical x-ray imaging equipment regulated under the Federal Food, Drug & Cosmetic (FD&C) Act and other regulations in the sphere of medical devices. In particular, by the virtue of the present guidance, the authority intends to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure more efficient and consistent regulatory review of submissions for these products. As further stated by the authority, the industry conformance to certain IEC standards would provide, at a minimum, the same level of protection of public health and safety from electronic radiation as certain EPRC regulatory standards.
Under the general rule, the parties involved in operations with medical x-ray imaging devices, including medical device manufacturers and importers, are obliged to ensure compliance with the relevant EPRC regulations and procedures. Alternatively, they can provide a declaration of conformity to equivalent IEC standards, addressing the respective matters. In such a way, it will be possible to reduce the duplication of efforts for the parties involved while making the regulatory procedures more efficient and streamlining the review process in general.
The document also contains references to the applicable FDA-recognized voluntary consensus standards medical device manufacturers may refer to when demonstrating compliance with the applicable regulatory requirements. Additional information on the matter is provided in the respective guidance document issued by the FDA.
In accordance with the current legislation, medical x-ray imaging devices could be subject to regulation both as medical devices (under section 201(h) of the FD&C Act) and as electronic products (under section 531(2) of the FD&C Act). Consequently, the said products should comply with the relevant regulatory requirements for medical devices and electronic products.
The FDA further acknowledges a certain overlap in the requirements established by the regulatory authorities entitled to conduct oversight with respect to medical x-ray imaging devices. By the virtue of the present guidance, the FDA intends to improve legal clarity, making the respective regulatory processes and procedures more efficient. As it is stated by the authority, the document addresses the following main spheres:
- Product conformance to IEC standards; and
- Compliance with EPRC performance standards.
Regulatory Requirements in Detail: Medical Devices Framework
First of all, the document describes in detail the regulatory requirements introduced under the medical devices framework. The general risk-based classification approach provides that any and all medical devices allowed to be marketed and used in the US are divided into three classes from I to III where the first one is the lowest in terms of the applicable risk, and the third one is the highest. When determining the proper class the device in question should be assigned to, one should consider the intended use of the product and the risks associated thereto.
According to the guidance, Class I (low-risk) medical devices are subject to general controls, addressing such aspects as adulteration, misbranding, registration, banned devices, notifications, and other remedies, records, and reports. The appropriate requirements are set forth by the regulations dedicated to labeling, reporting, establishment registration, device listing, and quality system regulation. The authority also mentions that most Class I medical devices could be placed on the market without FDA clearance of a 510(k) submission.
As further explained by the FDA, for Class II devices, manufacturers must comply with general controls and applicable special controls and are subject to premarket notification (510(k)) requirements prior marketing, unless otherwise exempted (21 CFR 860.3(c)(2)).
The products with the highest associated risk – Class III medical devices – are subject to the respective level of regulatory scrutiny. In particular, for such products, manufacturers must comply with general controls and generally must receive FDA approval of a premarket approval application (PMA) that demonstrates the safety and effectiveness of the device prior to marketing (21 CFR 860.3(c)(3)).
The guidance further highlights the key points related to compliance with the applicable EPRC regulations intended to ensure protection against hazardous and unnecessary exposure to radiation when using electronic products. Under the existing regulatory framework, such medical devices should comply with the respective performance standards. According to the guidance, the relevant requirements are set forth by the following regulations:
- 21 CFR 1002.20: Reporting of accidental radiation occurrences;
- 21 CFR 1002.30: Records to be maintained by manufacturers;
- 21 CFR 1002.40: Records to be obtained by dealers and distributors;
- 21 CFR Part 1003: Notification of defects or failure to comply;
- 21 CFR Part 1004: Repurchase, repairs, or replacement of electronic products;
- 21 CFR 1010.2: Certification;
- 21 CFR 1020.30: Diagnostic x-ray systems and their major components;
- 21 CFR 1020.31: Radiographic equipment;
- 21 CFR 1020.32: Fluoroscopic equipment;
- 21 CFR 1020.33: Computed tomography (CT) equipment.
In summary, the present FDA guidance provides an overview of the existing regulatory framework for medical x-ray imaging devices. The document outlines the scope of regulations and standards the said devices should comply with and also describes the approach to be applied.
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