The new article provides additional details regarding the specific aspects associated with dental curing lights and the regulatory requirements they are subject to under the existing legal framework.
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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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to the regulatory requirements for dental curing lights. Once finalized, the document will provide an overview of the applicable rules and regulations, as well as additional clarifications and recommendations to be taken into consideration by the parties involved in order to ensure compliance.
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 existing legal framework and has been agreed with the authority in advance.
The scope of the guidance covers certain specific aspects to be considered by the parties involved in order to ensure the completeness of the relevant applications.
Biocompatibility
The authority mentions that dental curing lights contain materials that come into contact with patients, which may induce harmful biological responses during their intended use. Thus, determining the biocompatibility of all patient-contacting materials present in the device is essential.
If the device is identical in chemical composition, manufacturing, and processing methods to dental curing lights with a history of safe use, referencing previous testing experience or relevant literature may be appropriate. For some device materials, providing a reference to a recognized consensus standard or a Letter of Authorization (LOA) for a device Master File (MAF) might be suitable.
If a legally marketed predicate device with the same nature of contact and contact duration using the same materials and manufacturing process cannot be identified, conducting and providing a biocompatibility evaluation as described in ISO 7405 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry is recommended. According to the FDA guidance “Use of International Standard ISO 10993-1 ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, when FDA-recognized consensus standards exist for a particular device type, the biocompatibility recommendations in the device-specific consensus standard should be used instead of the recommendations in ISO 10993-1.
The biocompatibility evaluation should explain the relationship between identified biocompatibility risks, available information to mitigate these risks, and any remaining knowledge gaps. Identifying any biocompatibility testing or other evaluations conducted to mitigate any remaining risks is necessary.
The authority expects the applicants to consider the guidance or standard recommendations, which identify the types of biocompatibility assessments, as well as recommendations on conducting related tests.
According to ISO 7405 and ISO 10993-1, dental curing lights are surface devices for limited contact duration.
The biocompatibility evaluation should address the following endpoints:
- Cytotoxicity
- Sensitization
- Irritation or intracutaneous reactivity
Software
Device software functions in dental curing lights ensure the control of the operation and output of the curing light, while adequate software testing ensures the device functions as intended. In this respect, the applicants should refer to the FDA guidance “Content of Premarket Submissions for Device Software Functions” for a discussion of the software information that should be provided in the submission.
This guidance outlines the recommended information to include in a premarket submission based on the “Documentation Level” associated with the device. Generally, the device software functions for dental curing lights require a “Basic” Documentation Level.
However, new or unusual indications, applications, or technological characteristics may necessitate an Enhanced Documentation Level. A full description of the device software functions supporting the operation of the subject device following this software guidance should be provided.
This recommendation applies to original devices/systems and any software changes made to already-marketed devices. Changes to software must be revalidated, reverified, and documented per Design Controls, 21 CFR 820.30(g)(1), and documented in the Design History File, 21 CFR 820.30(j).
Some software changes may warrant the submission of a new 510(k). For further information, the applicants should refer to “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”.
If the device includes off-the-shelf software, additional information should be provided as recommended in the FDA guidances “Off-the-Shelf Software Use in Medical Devices” and “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software”. If the device is a multiple-function device product and includes software functions considered “other functions”, as described in the guidance “Multiple Function Device Product: Policy and Considerations”, the applicants are expected to consider the recommendations in this guidance when preparing the software documentation for a premarket submission.
Overall, documentation related to device software functions should provide sufficient evidence to describe the role of the software in the device’s intended use and demonstrate that the software functions as designed.
Cybersecurity
Dental curing lights containing software or firmware and the ability to connect to the internet can expose the device to cybersecurity risks. These risks can result in compromised device functionality, loss of device availability, loss of data (medical or personal) availability or integrity, or exposure of other connected devices or networks to security threats, potentially leading to patient injury.
If the device meets the definition of a cyber device under section 524B(c) of the FD&C Act, cybersecurity documentation under section 524B(b) of the FD&C Act is required as part of the premarket submission. In this respect, applicants should refer to the FDA cybersecurity guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” for a discussion of the cybersecurity documentation to provide in the submission.
Conclusion
In summary, the present guidance highlights certain specific regulatory aspects to be considered by the parties interested in placing dental curing lights on the US market.
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