The new article addresses the aspects related to enforcement actions the authority may take, and also describes the various types of 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 terms of their conformance with IEC standards they are subject to since being electronic products. The document describes the approach the authority will apply when assessing the use of relevant standards, provides additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by medical device manufacturers and other parties involved 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, an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed with the authority in advance. 

The scope of the guidance covers, inter alia, the aspects related to compliance and enforcement.

Compliance and Enforcement: Key Points 

Under the general rule, should the medical device manufacturer fail to comply with the applicable regulatory requirements, the authority is intended to take enforcement actions. 

Should the manufacturer decide to submit a declaration of conformity to demonstrate compliance with specific regulatory requirements, it will be necessary to declare conformity to the relevant IEC standards by the virtue of the following the appropriate testing program. The quality system to be developed and implemented by the medical device manufacturer should duly address various aspects related to the radiation safety and conformity to the applicable standards through design verification and validation. Furthermore, it is also stated that the results of such testing should be duly documented, and the relevant records should be kept by the manufacturer as prescribed by the applicable record-keeping requirements to be provided to the authority upon request. According to the guidance, FDA will consider a product to be in violation of the electronic product performance standards if FDA finds that a manufacturer’s testing program does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electrons products comply with the appropriate standards. 

As further described in the document, when issuing a declaration of conformity and demonstrating compliance with the relevant standards and amendments thereto, the manufacturer declares and confirms that the appropriate design specifications in terms of radiation emission have been established. Should the product in question fail to comply with the said specifications, it is considered to have an electronic product defect. In such a case, the product could be subject to repurchase, repair, or replacement as required under the applicable regulatory requirements. 

At the same time, the authority additionally emphasizes that the present document is not intended to introduce changes to the approach the authority applies with respect to the enforcement of correction of such defects. As prescribed by the relevant regulation, medical device manufacturers, as well as importers of medical devices are obliged to notify the authority of any radiation safety defects identified, while the authority will, in its turn, notify the authority about the issues discovered. The regulation 21 CFR part 1004 requires a medical device manufacturer to take necessary actions to address the issue identified including, inter alia, repurchase, repair, or replacement of an affected product without charge in accordance with the plan to be approved by the authority. The applicable regulation entitles the authority to review and approve or reject the corrective action plans developed by medical device manufacturers.

IEC Standards and Specific Device Types 

The document also describes the aspects related to the applicability of IEC standards to specific device types. In particular, the IEC is based on a tiered structure of the standards: general standards, collateral standards, and particular standards. These types of standards are to be interpreted as follows:

  • The base standard (e.g., IEC 60601-1 for medical electrical equipment) is called the general standard;
  • Collateral standards (e.g., IEC 60601-1-3 for radiation protection in diagnostic x-ray equipment) provide general specifications for safety that are applicable to a subgroup of devices covered by the general standard, or a specific characteristic of all equipment covered by the general standard that is not fully addressed in the general standard.
  • Particular standards apply to specific types of equipment (e.g., IEC 60601-2-43 for interventional fluoroscopy systems), and may replace, add to, amend, or remove conditions contained in the general or collateral standards, as appropriate for the specific type of equipment under consideration. This type of standard could also be used to add details related to safety and performance.

As further explained by the authority, the references to applicable standards usually apply to all the aforementioned types of standards. It is also important to mention that in case of conflicting conditions, a particular standard will prevail over the collateral and general ones. 

In summary, the present FDA guidance provides additional clarifications regarding the way IEC standards should be applied with respect to medical x-ray imaging equipment. The scope of the guidance covers the aspects related to the enforcement actions the authority may take in response to non-compliances identified, and also describes the existing types of standards medical device manufacturers may refer to when demonstrating compliance with the applicable safety- and performance-related requirements. 



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