The new article highlights the aspects related to the declaration of conformity, the applicable certification requirements, and also the information to be shared by the manufacturers with other parties involved in the use of x-ray equipment.
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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 dedicated to medical x-ray imaging devices’ conformance with IEC standards. The guidance outlines the scope of applicable standards, and also describes the way conformance to the standards could be used when demonstrating compliance to the applicable regulatory requirements such devices are subject to under the existing regulatory framework.
It is also important to mention that FDA guidance documents are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications regarding the respective requirements, as well as recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the current legislation and has been agreed with the authority in advance.
DoC Submission
Under the general rule, if manufacturers and importers elect to conform to a recognised and applicable IEC standard to meet the applicable requirements of an EPRC performance standard, they must complete a declaration of conformity that certifies that the device is in conformity with the standard and include the declaration as part of a premarket submission, as applicable to the device type. The authority further explains that in case the applicable regulatory requirements the device in question is subject to do not require a declaration of conformity to be submitted before placing the device on the market, such a declaration should be duly kept by the manufacturer to be provided to the authority upon request. In this respect, the authority also refers to the guidance document dedicated to the use of voluntary consensus standards in premarket submissions.
Certification
The scope of the guidance also covers the aspects related to certification that x-ray imaging devices should undergo. As set forth by regulation 21 CFR 1010.2(a), manufacturers of diagnostic x-ray systems, and their major components, for which an applicable EPRC performance standard is in effect, including those that conform to applicable IEC standard to meet EPRC performance standards, must provide certifications for their products. According to the document, the details of the said certification should be duly communicated to the parties involved in the supply of medical devices in question to confirm that they are fully compliant with the applicable regulatory requirements. Furthermore, the information on certification should be included in the label the medical device should have in a way accessible when the device is ready to be used. The information should be provided in English.
According to the guidance, such label should include the following details:
- Reference to the applicable regulation, including specific section;
- Reference to the applicable IEC Standard, including its number and edition number;
- Indication of all the dates related to the standard (publication, amendments), and
- Reference to the relevant FDA guidance and the date it was published (latest revision).
The guidance further provides an example of such a label:
“Complies with 21 CFR Subchapter J including sections 21 CFR 1020.30 and 1020.33, partially by conforming with IEC 60601-2-44 ed1.0 (2009), including Amendment 1 (2012), in accordance with section 514(c)(1)(A) of the FD&C Act as outlined in “Medical X-Ray Imaging Devices: Conformance with IEC Standards,” dated [date of issuance of final guidance]”.
As set forth by the applicable regulation, the certification should be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with a good manufacturing practice. The authority additionally emphasizes that the aspects related to radiation safety and conformity to the applicable standards should be duly addressed in the quality system to be developed by the medical device manufacturer by the virtue of design controls. Furthermore, the results of such testing should be properly documented, and the appropriate records should be duly kept by the manufacturer to be provided to the authority upon request.
Information to be Shared
The authority also outlines the scope of information related to x-ray equipment to be shared by the manufacturers with assemblers and other parties involved. In accordance with 21 CFR 1020.30(g), manufacturers of such products are obliged to provide instructions for assembly, installation, adjustment, and testing (AIAT) to assure that the product will comply with applicable performance standard provisions. As explained by the FDA, the above is necessary to ensure the continuous safety of x-ray imaging devices being radiation-emitting products. In order to comply with this requirement, medical device manufacturers should take additional actions, hence, mere compliance with the applicable standard will not suffice.
According to the guidance, in order to ensure compliance with the abovementioned requirements, the manufacturer would have to include a Radiation Safety Specification and Testing Comparison Document in their AIAT documentation. The said document should contain the details an assembler will need in order to test the device in question to make sure it complies with the applicable requirements in terms of radiation safety.
In summary, the present FDA guidance highlights specific aspects related to medical x-ray imaging devices and their conformity to the applicable IEC standards. The scope of the guidance covers the aspects related to a declaration of conformity to be issued by the manufacturer, certification such products should undergo, as well as information to be shared with the parties involved in the maintenance and use of x-ray equipment to ensure their continued safety and prevent exposure to unnecessary radiation-related risks.
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